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                                                                                 EXHIBIT 10.1                                  Contract No. 75A50120C00034 Development of an mRNA Vaccine for SARS-CoV-2  CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND REPLACED WITH “[***]”. SUCH IDENTIFIED INFORMATION HAS BEEN   EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF DISCLOSED.                                            Table of Contents            PART I – THE SCHEDULE ........................................................................................................ 2  B. SUPPLIES/SERVICES AND COST/PRICE ................................................................................... 2  C. DESCRIPTION / SPECIFICATIONS / WORK STATEMENT ................................................... 7  D. PACKAGING AND MARKING (if applicable) ............................................................................ 14  E. INSPECTION AND ACCEPTANCE ............................................................................................. 14  F. DELIVERABLES / PERFORMANCE .......................................................................................... 15  G.        CONTRACT ADMINISTRATION .................................................................................. 34  H.        SPECIAL CONTRACT REQUIREMENTS ................................................................... 39            PART II – CONTRACT CLAUSES ......................................................................................... 47  I. CONTRACT CLAUSES .................................................................................................................. 47            PART III – LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS ......... 51  J. LIST OF ATTACHMENTS ............................................................................................................ 51                                                                          Page 1 of 51  ACTIVE/104412070.3  





 






                                               Contract No. 75A50120C00034 Development of an mRNA Vaccine for SARS-CoV-2  CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND REPLACED WITH “[***]”. SUCH IDENTIFIED INFORMATION HAS BEEN   EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF DISCLOSED.            PART I – THE SCHEDULE                  B.  SUPPLIES/SERVICES AND COST/PRICE                      B.1     Brief Description of Supplies/Services                      The Department of Health and Human Services (HHS), Office of the Assistant Secretary for Preparedness and Response (ASPR),                    Biomedical Advanced Research and Development Authority (BARDA) requires the contractor(s) to develop a mRNA vaccine to                    licensure for the prevention of COVID-19. The project will entail pre-clinical and Phase 2 and Phase 3 clinical studies sufficient                    to demonstrate the safety and efficacy of the proposed vaccine(s); CMC development, scale-up, scale-out and validation of                    manufacturing capacities, including bulk drug substance and fill and finished drug product, with a capacity of 100 million doses                    by 2021 and all program management and regulatory activities necessary to achieve FDA licensure of the vaccine. The project                    shall be accomplished on an accelerated timeline, with parallel activity WBS, aggressive manufacturing scale-up, risk                    management, and taking advantage of any regulatory flexibilities. Contract terms include a requirement for domestic production                    of vaccine and assurance of material sourcing for vaccine production during execution of the project.                      B.2     Price/Cost                      This contract contains the price/cost provisions agreed upon by the Government and the Contractor.                          B.2.1    Contract Budget Ceiling                        The contract has a cost/price ceiling that the Contractor exceeds at its own risk. The Contractor is responsible for managing                        its performance in accordance with the final scope of work and costs/prices incorporated into the contract. The Government                        is not obligated to reimburse the Contractor for costs incurred in excess of costs/prices agreed upon at time of award. The                        contract ceiling is $483,298,520.00.                          B.2.2    Contract Periods                        This contract consists of pre-award cost (CLIN 0001), a base period for the Development of mRNA vaccine to BLA (CLIN                        0002) and one (1) option period for the Domestic Manufacturing Scale-Out (CLIN 0003).                      B.3     Contract Line Item Numbers (CLINs) Schedule                      This is a Cost-Plus-Fixed-Fee (CPFF), contract.                          B.3.1    Base Period of Performance                        The base period of performance (POP) includes pre-award cost (CLIN 0001) and the Development of mRNA vaccine to                        BLA (CLIN 0002).                                   a.  CLIN 0001 costs shall be pre-award cost incurred by Moderna, with a do not exceed cost of [***].                                 b.  CLIN 0002 costs shall cover the base period statement of work that consists of the development of mRNA                                     vaccine to BLA.                                 c.   These are cost-plus-fixed-fee CLINs with a CPFF structure, [***].                                 d.  Monies shall be provided for the total cost of performance from the Department of Health and Human                                     Services.                                 e.  The Contractor shall maintain records of all contract costs and such records shall be subject to the Audit and                                     Records-Negotiation clause.                                 f.  It is estimated that the amount currently allotted will cover performance of the contract through [***] for the                                     base period.                                                                                                        Page 2 of 51  ACTIVE/104412070.3    





 






                                               Contract No. 75A50120C00034 Development of an mRNA Vaccine for SARS-CoV-2  CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND REPLACED WITH “[***]”. SUCH IDENTIFIED INFORMATION HAS BEEN   EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF DISCLOSED.                       Pre-Award Period of Performance: [***]                    Table 1                                                                                                                                           Estimated Period                                              Management Fee                     CLIN                       Supplies/Services   Estimated USG Cost                                 Total                             of Performance                                                     (Profit)                      0001                        Pre-Award Cost            [***]              [***]                    [***]                        Base Period of Performance: [***]                    Table 2                                                                                                                                            Estimated Period                                                    Management Fee                   CLIN                          Supplies/Services     Estimated USG Cost                               Total                            of Performance                                                         (Profit)                                                                                                                                           Development of mRNA                    0002                                                      [***]             [***]                   [***]                                                 vaccine to BLA                            B.3.2    Option Period 1                    This option period includes all Kit Build-Out activities for the facility under CLIN 0003, and may overlap with the base                    period.                      CLIN 0003 is under a CPFF structure, [***]                                                                                                                                           Estimated Period of                    Estimated USG      Management Fee                     CLIN                          Supplies/Services                                                 Total                                  Performance                              Cost              (Profit)                                                       Domestic        [***]               [***]                      [***]                     0003                           Manufacturing                                                      Scale-Out                            B.3.3    Total Contract Value                            The total potential value of this contract, including all CLINs 0001, 0002 and option CLIN 0003is $483,298,520.00.                        B.4     Advanced Understandings                      This contract contains advanced understandings between the Government and the Contractor. Specific elements of cost, which                    normally require prior written approval of the Contracting Officer before incurrence of the cost, will be included in this Section if                    the Contracting Officer has granted approval prior to contract award.                          B.4.1    Rights of first refusal – mRNA Vaccines                          [***]                                                                                                        Page 3 of 51  ACTIVE/104412070.3    





 






                                               Contract No. 75A50120C00034 Development of an mRNA Vaccine for SARS-CoV-2  CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND REPLACED WITH “[***]”. SUCH IDENTIFIED INFORMATION HAS BEEN   EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF DISCLOSED.                         B.4.2    HHS reserves the right to exercise priorities and allocations authority with respect to this contract, to                         include rating this order in accordance with 45 CFR Part 101, Subpart A—Health Resources Priorities and Allocations                        System                          B.4.3    Earned Value Management (EVM) Lite Requirements                          The Contractor shall use an Earned Value Management (EVM) System for all retrofit and development activities of the                        anticipated requirement, that is consistent with the “7 Principles of Earned Value Management Tier 2 System Implantation                        Intent Guide” attached to this contract. Alternative systems may be submitted to the Contracting Officer for consideration                        and approval.                          B.4.4    Public Readiness and Emergency Preparedness Act (“PREP ACT”) Coverage                          The Federal Government may not use, or authorize the use of, any products or materials provided under either this                        agreement or any future purchase from Recipient's domestic manufacturing capacity unless such use occurs in the United                        States and is protected from liability under a declaration issued under the Public Readiness and Emergency                        Preparedness Act, 42 U.S.C. § 247d‐6d.                          B.4.5    Provisions to Applicable Costs                        This section prohibits or restricts the use of contract funds which includes the following items (costs unallowable unless                        otherwise approved by the Contracting Officer):                                   a.      Acquisition, by purchase or lease, of any interest in real property;                                 b.      Purchase of lease of any item of general purpose office furniture or office equipment regardless of dollar                                         value;                                 c.      Accountable Government Property (as defined by HHS Government property policies                                 d.      Overtime;                                 e.      General scientific meetings/conferences;                                 f.      Travel costs including foreign travel;                                 g.      Costs incurred in the performance of any cost-reimbursement type subcontract (including consulting                                         agreements);                                 h.      Costs to be paid for the performance of a fixed-price subcontract that exceeds $250,000.00 (for                                         equipment purchases, $25,000.00 per unit);                                 i.      Refreshments and Meal Expenditures;                                 j.      Promotional Items Printing;                                 k.      Payment of regulatory submission fees to the FDA or other U.S. regulatory agency;                                 l.      BLA licensing or renewal fees;                                 m.      Pre-contract costs (other than those expressly set forth herein).                          B.4.6    Facility, Equipment and Product Ownership                          In the event the USG terminates this contract for other than default, all Contractor-acquired Government Furnished Property                        (GFP) [as defined by 52.245-1], to include process equipment, is to be assessed by a reputable third party firm that                        specializes in assigning fair market value of biopharmaceutical materials, supplies and equipment for the resale market. The                        USG will use this fair market value assessment in settlement, around the disposition of the GFP.                          Ownership and applicable usage rights of all materials/product (e.g. vaccines, validated lots) manufactured and/or acquired                        with Government funds, throughout the Contract’s entire period of performance, shall be retained by the USG. The                        Contracting Officer will direct the Contractor on the disposition (i.e. storage, transfer, disposal, etc.) of all Contractor-                        acquired/manufactured USG materials/product.                          B.4.7    [reserved] .                          B.4.8    Advanced Understanding: Milestone Review: the development of a COVID-19 vaccine is an accelerated                                 program. Progress for vaccine development will be continually assessed for go/no go decisions so that funding is                                 properly allocated across the MCM development effort to those candidates most likely to be available in time to                                 impact the COVID-19 public health emergency. Formal ‘go/no go’ assessments will be made at multiple points,                                 including:                                 [***]                                                                                                       Page 4 of 51  ACTIVE/104412070.3    





 






                                               Contract No. 75A50120C00034 Development of an mRNA Vaccine for SARS-CoV-2  CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND REPLACED WITH “[***]”. SUCH IDENTIFIED INFORMATION HAS BEEN   EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF DISCLOSED.                         B.4.9    Contractor Responsibility for Major Site Service & Utility System                        BARDA acknowledges that Moderna is offering to undergo potential upgrades to its manufacturing processes as outlined in                        the Technical Proposal. A preliminary assessment of major site service and utility systems of Contractor’s existing facility                        has deemed them adequate in supply and fitness to meet stated scope. However, if, during the course of executing this                        contract, Moderna discovers that major site service or utility replacement/upgrades at such facility are required to                        accomplish the scope of work, then the costs for said replacement/upgrades shall be covered by Moderna. As with any                        significant renovation Moderna has implied duty to disclose superior knowledge of site conditions. As contract work is                        performed, Moderna will ensure that the BARDA Contracting Officer’s Representative (COR) is fully informed of all issues                        that could affect cost or schedule. BARDA commits to work with Moderna to assess specific complex situations.                          Examples of major site-wide service/utility systems outside the envelope of Buildings to be warranted by Moderna:                                  Plant steam supply;                                Potable water/ Non-potable water supply (depending on the site, non-potable water could be fire hydrants);                                Sewer line\Sanitation line (post inactivation/ treatment) ;                                Site chiller/ chilled water supply;                                High and Low voltage Electrical feed(s) ;                                Network Infrastructure;                                Site-wide automation capacity;                                Perimeter fencing/ site security;                                Storm water;                                Gas (natural gas, site gas feeds);                                Fuel (generator fuel piping, this may be out of scope);                                Earthwork required to relocate, improve, or maintain site infrastructure such as manholes, duct banks, etc.                          All NEPA, state and local government environmental requirements are met for this project; any concerning issues have been                        disclosed to the USG before award.                          B.4.10   Evaluating the Expansion of Surge Vaccine Manufacturing Capacity                        The parties agree to develop and evaluate plans to further expand and diversify US-based domestic vaccine manufacturing                        capacity to respond to the pandemic. A draft framework will be completed within 60 days. This CMC domestic build-                        out/scale-out will further ensure that the United States has sufficient manufacturing capacity in response to the pandemic.                          B.4.11   Subcontracts                                     Prior written consent from the Contracting Officer in the form of Contracting Officer Authorization (COA) is                                     required for any subcontract that:                                       • Is of the cost-reimbursement type; or                                     • Is Fixed-Price and exceeds $250,000 or 5% of the total estimated cost of the Contract, whichever value is                                     greater.                                       The Contracting Officer shall request appropriate supporting documentation in order to review and determine                                     authorization, pursuant with FAR Clause 52.244-2, Subcontracts. After receiving written consent of the                                     subcontract by the Contracting Officer, the Contractor shall provide a copy of the signed, executed                                     subcontract and consulting agreement to the Contracting Officer.                                       On March 13, 2020, the U.S. President declared a national emergency due to the outbreak of the coronavirus.                                     The subcontractors and consultants listed below are currently engaged in the mRNA-1273 development                                     program and are tentatively approved to continue work. These subcontractors must complete the COA                                     process per FAR Clause 52.244-2 within 90 days. New vendors initiating work within the first 60 days of the                                     contract will be allowed to start, and COA requests will be submitted within 90 days.                                       Note: Consulting services are treated as subcontracts and subject to the ‘consent to subcontract’ provisions                                     set forth in this Article.                                       [***]                                                                                                        Page 5 of 51  ACTIVE/104412070.3    





 






                                               Contract No. 75A50120C00034 Development of an mRNA Vaccine for SARS-CoV-2  CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND REPLACED WITH “[***]”. SUCH IDENTIFIED INFORMATION HAS BEEN   EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF DISCLOSED.                                      [***]                           B.4.12   Performance Standard                      The contractor will not be in default under this agreement to the extent that it makes reasonable efforts to perform the services                    and produce and provide the items described in this contract.                          B.4.13   Limited Rights Data                      Notwithstanding any contrary representation by the Contractor on the System for Award Management or any contrary provision                    in this contract, the following categories of information developed at private expense will, if provided to the Government, be                    considered limited rights data subject to the restrictions specified in FAR 52.227-14, Alternate II. These restrictions apply to any                    component of information covered by this provision, regardless of whether a component is included in a contract deliverable.                    The Government will not reverse engineer or otherwise evaluate materials provided under this Contract to reproduce the type of                    information described below without Moderna’s prior written consent.                         [***]                            [***]                           [***]                     [***]                            [***]                           [***]                       [***]                       [***]                     [***]                     [***]                     [***]                     [***]                     [***]                                                                                                        Page 6 of 51  ACTIVE/104412070.3    





 






                                               Contract No. 75A50120C00034 Development of an mRNA Vaccine for SARS-CoV-2  CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND REPLACED WITH “[***]”. SUCH IDENTIFIED INFORMATION HAS BEEN   EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF DISCLOSED.                 C.  DESCRIPTION / SPECIFICATIONS / WORK STATEMENT                      C.1     Background                      Coronaviruses are potential epidemic threats and have been recognized on the World Health Organization's list of top emerging                    diseases likely to cause major epidemics and Coalition for Epidemic Preparedness Innovations priority pathogens list. No                    vaccines to prevent Coronavirus infection are currently available. The emergence of the SARS-CoV-2 virus creates an urgent                    need to rapidly develop vaccines to prevent COVID-19 disease. Developing and delivering a vaccine for highly transmissible,                    emerging diseases such as the SAR-CoV-2 virus requires breaking from traditional approaches. It requires parallel development                    activities, aggressive manufacturing scale-up, risk management and implementation of regulatory flexibilities. Many of these                    requirements are met by manufacturing ‘platforms’ that are capable of producing vaccines against different agents using                    essentially the same manufacturing systems. Suitable platforms are constituted by defined product production processes that                    allow significant planning for manufacturing scale and time to vaccine availability and will be supported by human safety and                    immunogenicity data targeting an one or more infectious agents. To meet the purposes of this contract, it is critical that the                    vaccine be produced in the United States. Domestic production of the vaccine is the only assurance that Americans will have                    access to the finished product.                      Moderna’s mRNA-based vaccine platform has been used to rapidly prepare vaccine candidates against Cytomegalovirus, Zika,                    Respiratory Syncytial Virus, Influenza, Human Metapneumovirus and Parainfluenza virus. Four of these candidates have been                    evaluated in Phase 1 clinical studies and shown to be safe and immunogenic. Moderna collaborated with the Vaccine Research                    Center, NIAID ("VRC/NIAID") to design a lead SARS-CoV-2 vaccine candidate encoding a stabilized pre-fusion, SARS-CoV-2                    Spike protein, which is more immunogenic than wild-type or subunit proteins. Moderna’s mRNA vaccine is currently being                    evaluated in pre-clinical studies and Phase 1 trials sponsored by the NIAID. For the purposes of this contract, Moderna will                    perform all work required to support the advanced development, scale-up manufacturing and FDA licensure of their lead SARS-                    CoV-2 vaccine candidate(s). This work includes preclinical development of mRNA vaccines to demonstrate safety and efficacy                    against COVID-19, mRNA vaccine process and manufacturing scale-up development, product lot release assay development and                    process validation, production of clinical material and consistency lots clinical evaluation studies for safety, immunogenicity and                    efficacy; and fill/finish capacity evaluation, expansion, and validation.                      The Governments has determined a bona fide need for each non-severable discrete work segment which will conclude upon the                    completion of a defined task(s) that provides independent merit and value to the Government. The Contractor must achieve a                    defined end-point required in each discrete work segment, as outlined in Section F of this contract, before the Government will                    consider exercising any of the follow-on option segment(s). The Contractor's success in completing the required tasks under each                    work segment must be demonstrated through the Deliverables and Milestones specified under Section B and F of this contract.                    Those deliverables will support the GO/NO GO Contract Milestones and Decision Gates specified therein. The GO/NO GO                    Contract Milestones and Decision Gates will constitute the basis for the Government’s decision, at its sole discretion, to exercise                    any follow-on option segment(s).                      The base and option segments under Contract Line Items (CLINs) 0001 through 0003 are event driven work segments rather than                    time driven CLINs. The funds for each independent, non-severable discrete work segment (requirement), regardless of duration,                    are separated by CLIN, and shall only be used for the scope of work covered in each discrete work segment. The periods of                    performance listed under each of the CLINs under Article B.2 and Article B.3 are estimated time periods. Those individual time                    periods may be extended by mutual agreement of the parties to complete the tasks required under each work segment. It is                    possible that more than one independent, non-severable discrete work segment (requirement), may be awarded at one time and                    that individual CLINs may overlap and/or proceed concurrently                      C.2     Statement of Work                    Independently, and not as an agent of the United States Government, the contractor shall furnish all necessary services, qualified                    professional, technical, and administrative personnel, material, equipment and facilities, not otherwise provided by the Government                    under the terms of this contract, as needed to perform the tasks set forth below.                      mRNA Vaccine Development (WBS 1.0)                    The  Contractor,  Moderna,  Inc.  (“Moderna”)  shall  execute  the  preclinical,  clinical,  and  chemistry,  manufacturing  and  controls                    (CMC) activities required to license a vaccine against the SARS-CoV-2 virus (herein referred to as “mRNA vaccine”). Building                    upon  early  clinical  development  already  underway,  this  proposal  will  support  the  late  stage  development,  including  the                    demonstration  of  clinical  efficacy  and generation  of  a  dataset  supportive of  licensure.  Moderna  will  additionally  evaluate  the                    platform manufacturing capabilities relative to the needs for supply in response to a pandemic.                      Program Management (WBS 1.1)                     mRNA Program Management (WBS 1.1.1)                     Moderna’s mRNA program team is composed of a multidisciplinary, highly matrixed, group of functional leads with experience                    in, and responsibility for, integrating plans and operationalizing strategies across Research, Toxicology, CMC, Regulatory Affairs,                                                                                                       Page 7 of 51  ACTIVE/104412070.3    





 






                                               Contract No. 75A50120C00034 Development of an mRNA Vaccine for SARS-CoV-2  CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND REPLACED WITH “[***]”. SUCH IDENTIFIED INFORMATION HAS BEEN   EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF DISCLOSED.                     Clinical Development and Quality. Collectively, the team has advanced ten programs to first-in-human studies within five years.                    The group will be led by a program lead (PL) who will oversee and coordinate the activities necessary to meet program objectives.                    The PL will be the point of accountability for the development of mRNA vaccine. [***] . A program management office (PMO)                    will  be  responsible  for  managing  the  cost  and  schedule  constraints  of  the  contract  via  an  integrated  master  schedule  and                    corresponding budget, identifying and managing program risk, and ensuring contract compliance. With the input from the mRNA                    project team, the PMO will be responsible for coordinating the drafting of and management to an integrated development plan.                    Upon execution of the contract, weekly meetings with BARDA will be held to monitor program performance and monthly and                    annual reports will be will delivered to BARDA for the record.                      Nonclinical Toxicology (WBS 1.2)                    Development and Reproductive Toxicology of mRNA (WBS 1.2.2.1)                    To assess the risk of administering the vaccine to pregnant women, a complete GLP rat developmental and reproductive toxicology                    (DART) study is planned. Female Sprague Dawley rats will be dosed at the highest anticipated clinical dose level and include a                    control arm of phosphate-buffered saline (PBS). As is typical for DART evaluations for vaccines, the animals will be immunized                    three times prior to mating and two times during gestation. Each group will have two cohorts (one group will undergo Cesarean                    section with examination of the uteri and embryos; the other group will have natural delivery and will be terminated at weaning).                      Nonclinical (WBS 1.3)                    For the purposes of this proposal it is assumed that the VRC continues to support nonclinical activities to develop murine and non-                    human primate efficacy studies, and animal models to assess the potential of vaccine-enhanced disease. The scope of work below                    will execute additional robustness experiments in these developed models.                      Assess Disease Enhancement (WBS 1.3.3.1)                    [***]                     We plan to perform studies in mouse and NHPs to assess the theoretical risk of vaccine induced disease enhancement triggered by                    CoV infection following vaccination with imRNA vaccine. [***]                     [***]                    [***]                     Establish a Surrogate of Protection (WBS 1.3.3.2)                    The primary endpoint for accelerated approval of a SARS-CoV-2 vaccine would be a neutralization assay. This endpoint must be                    supported  with  a  body  of  pre-clinical  work  that  demonstrates  a  correlation  between  neutralizing  titers  and  efficacy  and  that                    quantifies a protective serologic threshold titer using the same neutralization assay. Murine and NHP efficacy models are being                    developed in parallel to the Phase 1 clinical study. Building on data from these preliminary models and studies, Moderna will                    conduct NHP efficacy and murine passive transfer studies to confirm and refine the surrogate of protection.                     Clinical (WBS 1.4)                     [***]                        Phase 2 Safety and Immunogenicity Study (WBS 1.4.2.1)                     [***]                     Phase 3 Pivotal Study:(WBS 1.4.3.1)                     I. Scenario in which SARS-CoV-2 virus is circulating: In this scenario a randomized controlled trial with prevention of disease                    endpoint would serve to demonstrate effectiveness of the vaccine.                    [***]                     II. Scenario in the absence of SARS-CoV-2 virus: In this scenario an efficacy study becomes infeasible.                     [***]                     Lot to Lot Consistency (WBS 1.4.3.2)                     [***]                     Pediatrics (WBS 1.4.3.3)                    [***]                     Regulatory (WBS 1.5)                                                                                                      Page 8 of 51  ACTIVE/104412070.3    





 






                                               Contract No. 75A50120C00034 Development of an mRNA Vaccine for SARS-CoV-2  CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND REPLACED WITH “[***]”. SUCH IDENTIFIED INFORMATION HAS BEEN   EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF DISCLOSED.                     IND Preparation and Filing (WBS 1.5.1.1)                     Moderna’s Regulatory Affairs group, in close collaboration with BARDA, will work to draft a comprehensive regulatory master                    plan to guide the preclinical, CMC and clinical development of mRNA within the first 90 days of the contract. An original                    investigational new drug application (IND) will be filed with the United States Food and Drug Administration (FDA) to support                    the clinical development of the Moderna product from Phase 2 onwards.                     IND Maintenance (WBS 1.5.1.2)                     The  Moderna-owned  IND  will  be  maintained  to  support  the  desired  clinical  development  plan.  As  needed,  meetings  will  be                    conducted to receive feedback and gain concurrence on the specifics of the development activities with the FDA.                     BLA Submission (WBS 1.5.2.1)                     Moderna will submit a Biologics License Application (BLA) and seek approval for the mRNA vaccine.                        CMC (WBS 1.6)                     CTM Manufacture for Phase 2 (WBS 1.6.3.2)                    [***]                     Process Development for Late Stage Clinical Supply (WBS 1.6.3.3)                     mRNA Process Development                     Technical Development will confirm and optimize the process parameters for mRNA manufacture. [***]                    [***]                     BLA Readiness (WBS 1.6.3.8)                    In support of the Biologics License Application (BLA) due to the nature of the proposed timeline, it is likely that Moderna will                    need  to  complete  some  of  process  validation  activities,  primarily  process  characterization,  after  the  completion  of  process                    performance qualification and before BLA filing. Moderna intends to rapidly develop a robust process for clinical manufacturing                    and PPQ, and then fully describe the acceptable design space for the process prior to BLA filing. Other activities to support this                    BLA  filing,  such  as  completing  raw  material  qualification  activities;  if  not  included  in  the  BLA  submission,  will  require  a                    supplement to the initial BLA. In the initial BLA filing Moderna will describe its control strategy to cover the gap between initial                    BLA filing and the BLA supplement.                     Process Development for Full Commercial Scale (WBS 1.6.4.1)                    The following section outlines the process development activities [***]. The goal of this work is to demonstrate the capability to                    produce mRNA at a scale that can support clinical demand.                    [***]                     [***]                     Analytical Method Development and Validation (WBS 1.6.5.2)                    [***]                     Characterization Assay Development and Implementation (WBS 1.6.5.3)                    [***]                     Stability Studies (WBS 1.6.5.4)                    Throughout the program, many studies will be undertaken [***] This includes studies using development bench scale material,                    engineering lot material, and GMP material. This body of data will be used to apply interim and long-term shelf life to the drug                    product and process intermediates.                      1.  Intellectual Property                    The parties agree that that data generated prior to entering into or outside the scope of the agreement will, when delivered to the                    USG, be considered to be limited rights data subject to the restrictions covered under FAR Clause 52.227-14 Alt II paragraph (g)(3).                    The government will obtain unlimited rights to data funded under this contract pursuant to FAR Clause 52.227-14. The parties                    rights to subject inventions developed during performance of this contract will be governed by the terms of FAR Clause 52.227-11                      2.  Use of Select Agents                                                                                                        Page 9 of 51  ACTIVE/104412070.3    





 






                                               Contract No. 75A50120C00034 Development of an mRNA Vaccine for SARS-CoV-2  CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND REPLACED WITH “[***]”. SUCH IDENTIFIED INFORMATION HAS BEEN   EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF DISCLOSED.                     As Moderna selects programs for demonstration of the platform, Moderna will defer to an HHS chaired committee of contracting,                    security, safety and scientific program management to assess the applicability of the facilities, regulations, policies, and                    procedures for meeting the U.S. requirements described in 42 CFR part 73, 7 CFR part 331, and/or 9 CFR part 121.                      3.  Laboratory Licenses Requirements                      Moderna will comply with all applicable requirements of Section 353 of the Public Health Service Act (CLIA, as amended). This                    requirement shall also be included in any relevant subcontract for services under the contract.                      4.  Target Product Profile           [***]                                                    [***]                                     [***]                                    [***]                                    [***]        [***]                                                              [***]                                         [***]         [***]                                                     [***]                                    [***]                                                                                [***]        [***]                                                              [***]                                    [***]                                  [***]                                         [***]        [***]                                     [***]                                  [***]                                         [***]        [***]                                     [***]                                  [***]        [***]                                                                                                            [***]         [***]                                    [***]                                  [***]                                         [***]        [***]                       [***]                                                                                [***]                                                                           [***]        [***]                                                                                                            [***]                                    [***]                                  [***]         [***]                                            [***]                                                                                                        Page 10 of 51  ACTIVE/104412070.3    





 






                                               Contract No. 75A50120C00034 Development of an mRNA Vaccine for SARS-CoV-2  CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND REPLACED WITH “[***]”. SUCH IDENTIFIED INFORMATION HAS BEEN   EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF DISCLOSED.         CONTRA-INDICATION                                                                     None                D.  PACKAGING AND MARKING (if applicable)                    Unless otherwise specified by the Contracting Officer, all deliverable items to be furnished to the Government under this contract                (including invoices) shall be made by first class mail, overnight carrier, or email, as described in Section F.                  All physical deliverables shall be preserved, packaged, and marked in accordance with normal commercial practices to meet the                packaging requirements of the carrier, including that which is necessary to prevent deterioration and damages due to the hazard of                shipping, handling, and storing. The Contractor shall guarantee that all required materials shall be delivered in immediate usable and                acceptable condition.                    E.  INSPECTION AND ACCEPTANCE                        E.1 Federal Acquisition Regulation Clauses Incorporated by Reference                      This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text.                    Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed                    electronically at this address: http://acquisition.gov/far/                  The following FAR clauses, pertinent to Section E, are hereby incorporated by reference:               FAR Clause         Title                                                               Date             52.246-2           Inspection of Supplies – Fixed Price                                Aug 1996             52.246-5           Inspection of Services – Cost Reimbursement                         Apr 1984             52.246-9           Inspection of Research and Development                              May 2001                  All work under this contract may be subject to inspection and final acceptance by the Contracting Officer or the duly authorized                representative of the Government. The Contracting Officer’s Representative (COR) is a duly authorized representative of the                Government and is responsible for the inspection and acceptance of all items/activities to be delivered and or completed under this                contract.                                                                                                        Page 11 of 51  ACTIVE/104412070.3    





 






                                               Contract No. 75A50120C00034 Development of an mRNA Vaccine for SARS-CoV-2  CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND REPLACED WITH “[***]”. SUCH IDENTIFIED INFORMATION HAS BEEN   EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF DISCLOSED.                 F.  DELIVERABLES / PERFORMANCE                    F.1     Federal Acquisition Regulation Clauses Incorporated by Reference                      This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text.                    Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed                    electronically at this address: http://acquisition.gov/far/                      The following FAR clause, pertinent to Section F, is hereby incorporated by reference:               FAR Clause         Title                                                               Date             52.242-15          Stop-Work Order, Alternate I (Apr 1984)                             Aug 1989                           F.1.1        A pandemic facility and/or operational management plan including change procedures from normal to                        pandemic operations. Prepare an operational plan to continue operations in the event of a declared pandemic emergency                        (Draft within 15 days of award, Final within 30 days of award).                          F.1.2        Data Management Plan                          The Contractor shall develop and implement data management and quality control systems/procedures, including                        transmission, storage, confidentiality, and retrieval of all contract data; provide for the statistical design and analysis of data                        resulting from the research; provide raw data or specific analyses of data generated with contract funding to the Project                        Officer, upon request.                            F.1.3        Standard Operating Procedures                        The Contractor shall make internal and, to the extent possible, Subcontractor Standard Operating Procedures (SOPs)                        available for review by the Government on-site at Contractor’s facility, upon request from the COR or CO. At Contractor’s                        election, SOPs may be provided electronically.                            F.1.4        Evaluation of Fill Finish Alternatives                        The Contractor shall submit a Draft Final and Final Report describing the fill finish alternatives evaluated, the evaluation                        method and criteria used, cost comparison, and recommendation for which fill finish alternative to move forward. The draft                        report shall be due within thirty (30) days after completion of analysis. Subcontractor-prepared reports, on behalf of the                        Contractor, shall be submitted to the COR and CO for review and comment, no later than five (5) business days after receipt                        by the Contractor. BARDA shall provide written comments to the Draft Final Report within fifteen (15) days after the                        submission. The Final Report shall be due thirty (30) days after receiving comments on the Draft Final Report from                        BARDA. If corrective action is recommended, the Contractor must address, in written, all concerns raised by the                        Government.                          F.1.5        Supply Chain Resiliency Plan                        The partner contractor shall have a comprehensive Supply Chain Resiliency Program that provides for identification and                        reporting of critical components associated with the secure supply of drug substance, drug product, and work-in-process                        through to finished goods. A critical component is any material that is essential to the product or the manufacturing process                        associated with that product. Included in the definition are consumables and disposables associated with manufacturing.                        NOT included in the definition are facility and capital equipment.                          Consideration of critical components includes the evaluation and potential impact of raw materials, excipients, active                        ingredients, substances, pieces, parts, software, firmware, labeling, assembly, testing, analytical and environmental                        componentry, reagents, or utility materials which are used in the manufacturing of a drug, cell banks, seed stocks, devices                        and key processing components and equipment. A clear example of a critical component is one where a sole supplier is                        utilized.                          Identification of key equipment suppliers and their locations, local resources and the associated planning and control                        processes at the time of award is important to the security of the medical countermeasure supply chain. These processes                        shall address planning and scheduling for active pharmaceutical ingredients, upstream, downstream, component assembly,                        finished drug product and delivery events as necessary for the delivery of product. Where multi-site manufacturing is                        integral to the delivery of contractual materials, it should be included as part of the planning and scheduling process.                        Communication for these requirements shall be updated as part of an annual review, or as necessary, as part of regular                        contractual communications.                                                                                                        Page 12 of 51  ACTIVE/104412070.3    





 






                                               Contract No. 75A50120C00034 Development of an mRNA Vaccine for SARS-CoV-2  CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND REPLACED WITH “[***]”. SUCH IDENTIFIED INFORMATION HAS BEEN   EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF DISCLOSED.                         The focus on the aspects of resiliency shall be on critical components and aspects of complying with the contractual delivery                        schedule. Delivery methods shall be addressed, inclusive of items that are foreign-sourced, both high and low volume,                        which would significantly affect throughput and adherence to the contractually agreed deliveries.                          For upstream and downstream processing, both single-use and re-usable in-place processing equipment, and manufacturing                        disposables also shall be addressed. For finished goods, the inspection, labeling, packaging, and associated machinery shall                        be addressed taking into account capacity capabilities.                          The partner contractor shall communicate the methodology for inventory control, production planning, scheduling processes                        and ordering mechanisms, as part of those agreed deliveries. For critical items these processes should provide visibility for                        key items over an adequate planning horizon that ensures effective control of the established supply chain for contractual                        deliveries. Production rates and lead times shall be understood and communicated to the HHS/ASPR/BARDA Contracting                        Officer or the Contracting Officer’s Representative as necessary.                          Production throughput critical constraints should be well understood by activity and by design, and communicated to                        contractual personnel. As necessary, communication should focus on identification, exploitation, elevation, and secondary                        constraints of throughput, as appropriate.                          Reports for critical items may be summarized with the following template:                   Critical Material                Supplier, Manufacturing /  Supplier Lead               Transportation / Shipping                      Name           Vendor         Distribution Location        Time        Shelf Life        restrictions                          The CO and COR reserve the right to request unredacted copies of technical documents, during the period of performance,                        for distribution within the Government, and Contractor will reasonably consider any such requests. Documents shall be                        provided within ten (10) days after CO issues the request. The Contractor may arrange for additional time if deemed                        necessary, and agreed to by the CO.                        F,2 Deliverables Schedule                      Successful performance of the final contract shall be deemed to occur upon performance of the work set forth in the Statement of                    Work attached to this contract as Attachment 1 (SECTION J-List of Attachments), and upon delivery and acceptance, as required                    by the Statement of Work, by the Contracting Officer, or the duly authorized representative pursuant to SECTION E-Inspection                    and Acceptance, of the following items listed below under heading 1 “Summary of Contract Deliverables” in accordance with the                    stated delivery schedule.                      The items specified below under heading 1 “Summary of Contract Deliverables”, as described in the Statement of Work which is                    Attachment 1 to this contract will be required to be delivered by the date(s) specified below and in accordance with any                    specifications stated in SECTION D- PACKAGING, MARKING AND SHIPPING, of this contract. All reports identified below                    relate solely to the development activity funded under this contract:             1. Summary of Contract Deliverables             Unless otherwise stated, each deliverable in the table below shall be provided as one (1) electronic copy to the COR, CS, and CO as           set forth in SECTION D.             In addition to or in replacement of electronic copies, the CO may direct the Contractor to submit the below deliverables via BARDA           Digital Resources Portal in machine readable format.                                                                                                        Page 13 of 51  ACTIVE/104412070.3    





 






                                               Contract No. 75A50120C00034 Development of an mRNA Vaccine for SARS-CoV-2  CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND REPLACED WITH “[***]”. SUCH IDENTIFIED INFORMATION HAS BEEN   EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF DISCLOSED.            Table 5                CDRL#         Deliverable     Deliverable Description                 Reporting Procedures and Due Dates                                                                                            01              Meetings                                                                                  Within one week of contract award                                                                                 Contractor shall provide agenda and establish                                                                                 a teleconference number at least 3 business                                            The contractor shall complete an initial days in advance of the teleconference unless                                            teleconference after contract award  notified that BARDA will supply one                                        Post Award        1. Outline activities for the next 30  COR edits/approves and instructs contractor               01.1                           Teleconference       days                             to distribute agenda prior to meeting by at                                              2. Discuss agenda items for the post- least 2 business days                                                award Kickoff Meeting (01.2)     Contractor provides meeting minutes to COR                                                                                 within 3 business days after the meeting                                                                                 COR reviews, comments and approves                                                                                 minutes within 10 business days                                                                                 Within a month of contract award, pending                                                                                 concurrence by the contracting officer                                                                                 Contractor shall provide itinerary and agenda                                                                                 at least 5 business days in advance of site                                                                                 visit or virtual meeting                                                                   The Contractor shall complete a      COR edits/approves and instructs contractor               01.2       Kickoff Meeting                                            Kickoff meeting after contract award to distribute agenda prior to meeting by at                                                                                 least 3 business days                                                                                 Contractor provides meeting minutes to COR                                                                                 within 3 business days after the meeting                                                                                 COR reviews, comments, and approves                                                                                 minutes within 10 business days                                                                                 Contractor provides agenda to COR no later                                                                                 than 2 business days in advance of meeting                                                                                 COR edits/approves and instructs contractor                                            The Contractor shall participate in  to distribute agenda prior to meeting                                            teleconferences every 2 weeks, with  Contractor distributes agenda and                           Every 2 weeks    BARDA to discuss the performance on               01.3                                                              presentation materials at least 24 hours in                           Teleconference   the contract. Meeting frequency can be advance                                            increased as needed during the course                                                                                 Contractor provides meeting minutes to COR                                            of the project                                                                                 within 3 business days of the meeting                                                                                 COR reviews, comments, and approves                                                                                 minutes within 6 business days                                            At the discretion of the government                                             the Contractor shall hold recurring                                                                                 Contractor shall provide itinerary and agenda                                            teleconference or face-to-face Project                                                                                 at least 5 business days, and presentation                                            Review Meetings up to four per year                                            either in Washington D.C or at work  materials at least 3 business days in advance                                                                   sites of the Contractor or sub-      of site visit                                                                   contractors. Face-to-face meetings   COR edits/approves and instructs contractor                                            shall alternate between Washington               01.4      Quarterly Meetings                                      to distribute agenda prior to meeting by at                                            DC and Contractor, sub-contractor    least 3 business days                                            sites. The meetings will be used to                                                                                 Contractor provides meeting minutes to COR                                            discuss contract progress in relation to                                            the Program Management               within 3 business days after the meeting                                            deliverables described below as well  COR reviews, comments, and approves                                            as study designs, technical,         minutes within 10 business days                                            regulatory, and ethical aspects of the                                            program.                                            The Contractor shall forward the dates  Contractor shall notify BARDA of upcoming               01.5        FDA Meetings                                            and times of any meeting with the    FDA meeting within 24 hours of scheduling                                                                                                       Page 14 of 51  ACTIVE/104412070.3    





 






                                               Contract No. 75A50120C00034 Development of an mRNA Vaccine for SARS-CoV-2  CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND REPLACED WITH “[***]”. SUCH IDENTIFIED INFORMATION HAS BEEN   EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF DISCLOSED.                 CDRL#         Deliverable     Deliverable Description                 Reporting Procedures and Due Dates                                            FDA to BARDA and make                Type A, B or C meetings OR within 24 hours                                            arrangements for appropriate BARDA   of meeting occurrence for ad hoc meetings                                            staff to attend the FDA meetings.    The Contractor shall forward initial                                            BARDA staff shall include up to a                                                                                 Contractor and FDA-issued draft minutes                                            maximum of four people (typically                                            COR and up to 3 subject matter       and final minutes of any meeting with the                                            experts)                             FDA to BARDA within 2 business days of                                                                                 receipt                                            Upon request of the Government, the                                             Contractor shall participate in a daily                                             check-in update with the project staff                                                                                                                           (via teleconference or email).                                                                                                                                                  The updates will address key cost,                                                                    schedule and technical updates. Daily                                             updates may be shared with senior                                            Government leaders during the                                                  COVID- 19 response and should be     No agenda will be required for the meeting                         Daily check in with provided on a non-confidential basis,  No meeting minutes are required                          project staff for unless the update includes confidential               01.6                                                              Contractor will provide bulleted email                            COVID-19        information in which case Contractor                                                                                 updates following any call or in lieu of a call                             Contract       shall provide the update in both                                            confidential and non-confidential    by 2PM for that day                                            formats.                                                                                       Daily check-ins may occur on                                            weekdays, excluding federal holidays.                                            Upon request of the Government,                                            check-ins may also occur on weekends                                            and on federal holidays, provided at                                            least 24 hours’ notice.                                                                                                        Page 15 of 51  ACTIVE/104412070.3    





 






                                               Contract No. 75A50120C00034 Development of an mRNA Vaccine for SARS-CoV-2  CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND REPLACED WITH “[***]”. SUCH IDENTIFIED INFORMATION HAS BEEN   EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF DISCLOSED.                                Technical                                                      02                            Reporting                                            1. The Integrated Program            Monthly Reports shall be submitted on the                                               Management Report (IPMR) is a     20th day of the month covering the preceding                                                                                                                       th                                              contractually required report     month; Annual Reports submitted on the 30                                                prepared by the contractor. IPMR  calendar day of the month after each contract                                               Formats 1, 3, 5, and 6 are required. anniversary. Monthly progress reports are                                               These formats will contain        not required for the months when the Annual                                               performance data and information  Report(s) are due, and Monthly/Annual                                               derived from the contractor's     Report(s) are not due during a month when                                               internal Earned Value Management  the Final Report (final version, not draft) is                                               System (EVMS) and Integrated      due (see deliverable 02.4). The COR and CO                                               Master Schedule (IMS). The        will review the monthly reports with the                                               Contractor’s EVMS shall comply    Contractor and provide feedback                                               with Earned Value Management’s    Contractor shall provide FINAL versions of                                               Seven (7) Principles.             reports within 10 business days after                                            2. An Executive Summary              receiving BARDA comments/edits                                               highlighting the progress, issues  Integrated Performance Management Report                                               and relevant manufacturing, non-  (IPMR) shall be developed according to the                                               clinical, clinical and regulatory                                                                                 instructions of Data Item Description (DiD)                                               activities. The Executive Summary                                                                      should highlight only critical issues #81861A                                               for that reporting period and     The CPR shall be provided on the 20th day of                                               resolution approach; limited to 2 the month covering the preceding month,                                               pages                             including the same month as the Annual                                            3. BARDA Contractor Clinical Trials  Report(s) is due                                               Information Sheet – covering      The IPMR required formats for this Contract                                               ongoing BARDA-sponsored               02.1                                                              shall be Formats 1 (WBS), 3 (Performance                                               clinical studies. This form shall             (Monthly)                         Monthly & Annual      provide data on relevant activities Measurement Baseline Changes and                         Technical Progress    during the period covered, by study Reconciliation), 5 (Variance Analysis Report                          Reports/Annual       site, including: cumulative       – Narrative Form), and 6 (Integrated Master                              Meeting          enrollment; new enrollments;               02.2                                                              Schedule)                                               screen failures; patients dropped             (Annual)                                               from study; AE and SAEs;                                               activation or inactivation of study                                               sites; investigator appointments or                                               changes; and status of IRB/IEC                                               review/approval/renewal                                            4. Progress in meeting contract                                               milestones organized by WBS,                                               overall project assessment,                                               problems encountered and                                               recommended solutions. The                                               reports shall detail the planned and                                               actual progress during the period                                               covered, explaining any differences                                               between the two and the corrective                                               steps                                            5. A three-month rolling forecast of                                               the key planned activities,                                               referencing the WBS/IMS                                            6. A tracking log of progress on                                               regulatory submissions with the                                               FDA number, description of                                               submission, date of submission,                                               status of submission and next steps                                            7. Estimated and Actual Expenses                                               a. This report shall also contain a                                               narrative or table detailing whether                                               there is a significant discrepancy                                               (>10%) at this time between the %                                                                                                       Page 16 of 51  ACTIVE/104412070.3    





 






                                               Contract No. 75A50120C00034 Development of an mRNA Vaccine for SARS-CoV-2  CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND REPLACED WITH “[***]”. SUCH IDENTIFIED INFORMATION HAS BEEN   EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF DISCLOSED.                                                  of work completed and the                                                      cumulative costs incurred to date.                                               Monthly and actual expenses                                               should be broken down to the                                               appropriate WBS level. This                                               section of the report should also                                               contain estimates for the                                               Subcontractors’ expenses from the                                               previous month if the Subcontractor                                               did not submit a bill in the previous                                               month. If the subcontractor(s) was                                               not working or did not incur any                                               costs in the previous month, then a                                               statement to this effect should be                                               included in this report for those                                               respective subcontractors If the                                               COR and CO are satisfied that the                                               contractor’s reporting is sufficient                                               to convey this information, this                                               section may be waived.                                            A draft Final Technical Progress                                               Report containing a summation of the                                             work performed and the results                                                 obtained over the entire contract. This                                             report shall be in sufficient detail to                                                                                                                           fully describe the progress achieved                                            under all milestones. Report should                                             contain a timeline of originally                                               planned and baselined activities and  The Draft Technical Progress Report shall be                                            milestones overlaid with actual      submitted 75 calendar days before the end of                                            progress attained during the contract.                                                                                 the PoP and the Final Technical Progress                                            Descriptions and rationale for               02.3                         activities and milestones that were not Report on or before the completion date of              (Draft)      Draft and Final  completed as planned should be       the PoP                         Technical Progress provided. The draft report shall be  COR will provide feedback on draft report               02.4           Report        duly marked as ’Draft’               within 15 calendar days of receipt, which the              (Final)                                                            Contractor shall consider incorporating into                                            The Final Technical Progress Report  the Final Report                                            incorporating feedback received from                                            BARDA and containing a summation                                            of the work performed and the results                                            obtained for the entire contract PoP.                                            The final report shall document the                                            results of the entire contract. The final                                            report shall be duly marked as ’Final’.                                            A cover letter with the report will                                            contain a summary (not to exceed 200                                            words) of salient results achieved                                            during the performance of the contract                                                                                 Draft report due within 45 calendar days                                                                                 after completion of analysis and at least 15                                                                                 business days prior to submission to FDA                                                                                 Subcontractor prepared reports received by                                                                                 the Contractor shall be submitted to the COR                                            Contractor shall provide Draft and               02.5                           Draft and Final  Final  Clinical/Non-Clinical  Study  and CO for review and comment no later              (Draft)                           Study Reports,   Reports to BARDA for review and      than 5 business days after receipt by                                     Clinical and Non-  comment.                             Contractor               02.6                              Clinical                                           The Government will provide written              (Final)                                                                                 comments to the Draft Report for Clinical /                                                                                 Non-Clinical Study reports within 15                                                                                 business days after the submission                                                                                 Final report due 30 calendar days after                                                                                 receiving comments on the Draft Final                                                                                                       Page 17 of 51  ACTIVE/104412070.3    





 






                                               Contract No. 75A50120C00034 Development of an mRNA Vaccine for SARS-CoV-2  CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND REPLACED WITH “[***]”. SUCH IDENTIFIED INFORMATION HAS BEEN   EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF DISCLOSED.                                              Report for Clinical and Non-Clinical Studies;                                                                                 If corrective action is recommended,                                                                                 Contractor must address all concerns raised                                                                                 by BARDA in writing                                                                                 Contractor shall consider revising reports to                                                                                 address BARDA’s recommendations prior to                                                                                 FDA submission                                                                                 Contractor will submit Manufacturing                                                                                 Reports at least 15 business days prior to                                            At BARDA’s request, Contractor shall FDA submission                                            provide Manufacturing Reports to     The Government will provide written                                            BARDA for review and comment         comments to the manufacturing report within                               FDA          prior to submission to FDA           15 business days after the submission               02.7        Manufacturing                                         If corrective action is recommended,                              Reports       The COR and CO reserve the right to                                                                                 Contractor must address all concerns raised                                            request within the PoP a non-                                            proprietary Manufacturing Report for by BARDA in writing                                            distribution within the USG          Contractor shall consider revising reports to                                                                                 address BARDA’s concerns and/or                                                                                 recommendations prior to FDA submission                                            Contractor will submit Product Development                                           Source Material Report                                           o                                           Within month of contract award                                            The Contractor shall submit a detailed o   Within 30 days of substantive changes                                            spreadsheet regarding critical project     are made to sources and/or materials                                            materials that are sourced from a      o   Or on the 6th month contract                                            location other than the United States,                              Product                                                  anniversary.                                            sources, and manufacturing sites,                           Development                                                                                     including but not limited to: physical               02.8       Source Material                                        The Government will provide written                                            locations of sources of raw and                         and Manufacturing                                       comments to the Product Development                                            processed material by type of material;                              Report                                            location and nature of work performed Source Material and Manufacturing Report                                            at manufacturing sites; and location within 15 business days after the submission                                            and nature of non-clinical and clinical  If corrective action is recommended,                                            study sites.                         Contractor must address all concerns raised                                           by BARDA in writing                                                                                  Contractor will submit Work Locations                                                                                 Report:                                                                                 Within 5 business days of contract award                                                                                 Within 30 business days after a substantive                                            The contractor shall submit detailed location or capabilities change                                            data regarding locations where work  Within 2 business days of a substantive                            Contractor      will be performed under this contract,               02.9                                                              change if the work performed supports                             Locations      including addresses, points of contact,                                            and work performed per location, to  medical countermeasure development that                                            include sub-contractors.             addresses a threat that has been declared a                                                                                 Public Health Emergency by the HHS                                                                                 Secretary or a Public Health Emergency of                                                                                 International Concern (PHEIC) by the WHO                                             The contractor shall submit detailed Contractor shall submit Clinical Reports on a                                            clinical reports during active clinical weekly basis starting when first patient is                                            trial enrollment to include at a     enrolled and ending when last patient is                           Clinical Report  minimum number of subjects screened  enrolled.               02.10       during Active    and enrolled, site activation status,                         Enrollment Periods safety reporting (SAEs), deviation                                            reports and database management.                                            Exact format TBD by COR and                                            contractor.                                                                                                      Page 18 of 51  ACTIVE/104412070.3    





 






                                               Contract No. 75A50120C00034 Development of an mRNA Vaccine for SARS-CoV-2  CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND REPLACED WITH “[***]”. SUCH IDENTIFIED INFORMATION HAS BEEN   EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF DISCLOSED.                                                                                    Draft study protocols will be submitted to                                                                                 COR electronically prior to finalization.                                                                                     o    BARDA will provide comments                                                                                          within 10 days of receipt of draft                                                                                          protocol                                            The contractor shall submit draft and    o    Contractor shall respond in writing               02.11      Study Protocols   final nonclinical and clinical study          to BARDA comments and                                            protocols to CO and COR                       recommendations prior to                                                                                          finalization of protocol.                                                                                                                                                                Final study protocols will be submitted to                                                                                 COR electronically no later than 10 business                                                                                 days prior to FDA submission                                                                                 Contractor will submit at least 15 days prior to                                            Contractor must submit a data package contract end date. Partial data-sets may also                                            consisting of all raw data produced  be requested for delivery prior to submission                                            under this contract. Data may be used of the Final Data Submission Package.                                            by BARDA for analysis, evaluation,                                            shared with other agencies, or shared                                            outside of the government consistent                             Final Data     with FAR 52.227-14. This submission               02.12        Submission      package must be delivered in a non-                              Package       proprietary format.                                                                                       If clinical trial data is included, that                                            data must be provided consistent with                                            applicable privacy laws to protect                                            personally identifiable information                                            (PII).                            Supplemental     Upon request and also as part of     Contractor shall provide the Technical                             Technical      deliverables the Contractor shall    Documents upon request from the CO or               02.13      Documents, Raw    provide raw data, data analysis, or data COR                           Data, or Data    report to BARDA.                             Analysis                                                                                            03               Audits                                            Contractor shall accommodate         If issues are identified during the audit,                                            periodic or ad hoc site visits by    Contractor shall submit a report to BARDA                                            BARDA. If BARDA, the Contractor,     detailing the finding and corrective action(s)                                            or other parties identifies any issues within 10 business days of the audit                                            during an audit, the Contractor shall                                                                                 COR and CO will review the report and                03.1       BARDA Audit      capture the issues, identify potential                                            solutions, and provide a report to   provide a response to the Contractor with 10                                            BARDA                                business days                                                                                 Once corrective action is completed, the                                                                                 Contractor will provide a final report to                                                                                 BARDA                                            In the event of an FDA inspection that  Contractor shall notify CO and COR within                                            occurs in relation to this contract and 10 business days of a scheduled FDA audit                                            for the product, or for any other FDA or within 24 hours of an ad hoc site                                            inspection that has the reasonable   visit/audit if the FDA does not provide                                            potential to impact the performance of                                                                                 advanced notice                                            this contract, the Contractor shall                                            provide the USG with an exact copy   Contractor shall provide copies of any FDA                03.2        FDA Audits      (non-redacted) of the FDA Form 483   audit report received from subcontractors                                            and the Establishment Inspection     that occur as a result of this contract or for                                            Report (EIR). The Contractor shall   this product within 1 business day of                                            provide the COR and CO with copies   receiving correspondence from the FDA or                                            of the plan for addressing areas of non-                                                                                 third party                                            conformance to FDA regulations for                                            GLP, GMP, or GCP guidelines as       Within 10 business days of audit report,                                            identified in the audit report, status Contractor shall provide CO with a plan for                                                                                                      Page 19 of 51  ACTIVE/104412070.3    





 






                                               Contract No. 75A50120C00034 Development of an mRNA Vaccine for SARS-CoV-2  CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND REPLACED WITH “[***]”. SUCH IDENTIFIED INFORMATION HAS BEEN   EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF DISCLOSED.                                               updates during the plans execution and addressing areas of nonconformance, if any                                            a copy of all final responses to the are identified                                            FDA. The Contractor shall also                                            provide redacted copies of any FDA                                            audits received from subcontractors                                            that occur as a result of this contract or                                            for this product. The Contractor shall                                            make arrangements for BARDA                                            representative(s) to be present during                                            the final debrief by the regulatory                                            inspector                                             BARDA reserves the right to          Contractor shall notify CO and COR a                                            participate in QA audits performed by minimum of 10 business days in advance of                                            the contractor. Upon completion of the upcoming, audits/site visits of subcontractors                                            audit/site visit the Contractor shall                                                                                 Contractor shall notify the COR and CO                                            provide a report capturing the findings,                                                                                 within 5 business days of report completion.                                            results and next steps in proceeding                                            with the subcontractor. If action is  COR and CO will review the report and                                            requested of the subcontractor,      provide a response to the Contractor with 10               03.3         QA Audits       detailed concerns for addressing areas business days                                            of non-conformance to FDA                                            regulations for GLP, GMP, or GCP                                            guidelines, as identified in the audit                                            report, must be provided to BARDA.                                            The Contractor shall provide responses                                            from the subcontractors to address                                            these concerns and plans for corrective                                            action                                                                                 A Draft is due 90 business days within                                                                                 contract award; updates to the RMP are due                                                                                 concurrent with Monthly Technical Progress                                            The Contractor shall provide an RMP  Reports. The contractor may choose to notify                                            that outlines the impacts of each risk in                                                                                 the government up to two times every three                                            relation to the cost, schedule, and                                                                   performance objectives. The plan shall months if there are no changes from the prior                         Risk Management             03.4                           include risk mitigation strategies. Each submission, and not submit an update                            Plan (RMP)                                            risk mitigation strategy will capture  BARDA will provide Contractor with a list                                            how the corrective action will reduce of concerns in response plan submitted                                            impacts on cost, schedule and        Contractor must address, in writing, all                                            performance                          concerns raised by BARDA within 20                                                                                 business days of Contractor’s receipt of                                                                                 BARDA’s concerns                                                                                 The IMS is to be submitted in both PDF and                                                                                 Microsoft Project Form to the COR                                            The contractor shall provide an IMS                                                                                 The first Draft of the IMS is due 30 business                                            that illustrates project tasks,                                                                                 within contract award                                            dependencies, durations throughout the                                     Integrated Master  period of performance, and milestones  The Government will request revisions             03.5                          Schedule (IMS)    (GO/NO-GO). The IMS must map to      within 10 business days, at which point the                                            the WBS, and provide baseline, and   schedule baseline for the period of                                            actual or forecast dates for completion performance will be set                                            of tasks                             Thereafter an updated IMS is due concurrent                                                                                 with Monthly Technical Progress Reports                                            Process for changing IMS activities  Due at least 10 business days prior to the                                            associated with cost and schedule as Contractor anticipating the need to                                            baselined. Contractor shall notify                             Deviation                                           implement changes                                            BARDA of significant proposed             03.6         Notification and                                            changes the IMS defined as increases                         Mitigation Strategy                                            in cost above 5% or schedule slippage                                            of more than 30 days, which would                                            require a PoP extension. Contractor                                                                                                       Page 20 of 51  ACTIVE/104412070.3    





 






                                               Contract No. 75A50120C00034 Development of an mRNA Vaccine for SARS-CoV-2  CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND REPLACED WITH “[***]”. SUCH IDENTIFIED INFORMATION HAS BEEN   EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF DISCLOSED.                                               shall provide a high level management                                             strategy for risk mitigation                                                                                 Due within 48 hours of activity or incident or                                                                                 within 24 hours for a security activity or                                            Contractor shall communicate to                                                                                 incident                                            BARDA and document all critical                                            programmatic concerns, issues, or    Email or telephone with written follow-up to                                            probable risks that have or are likely to COR and CO                                            significantly impact project schedule  Additional updates due to COR and CO                                            and/or cost and/or performance.      within 48 hours of additional developments                                            “Significant” is frequently defined as a  Contractor shall submit within 5 business             03.7         Incident Report   10% or greater cost or schedule      days a Corrective Action Plan (if deemed                                            variance within a control account, but necessary by either party) to address any                                            should be confirmed in consultation                                                                                 potential issues                                            with the COR. Incidents that present                                            liability to the project even without  If corrective action is deemed necessary,                                            cost/schedule impact, such as breach Contractor must address in writing, its                                            of GCP during a clinical study, must consideration of concerns raised by BARDA                                            also be reported                     within 5 business days of receiving such                                                                                 concerns                           Advanced R&D                                                      09                             Products                                            Upon request, Contractor shall provide  Contractor shall provide technical document                                            CO and COR with deliverables from    within 10 business days of CO or COR                                            the following contract funded        request. Contractor can request additional                                            activities: quality agreements between time on an as needed basis                                            contractors and sub-contractors,                                                                   process Development Reports, Assay   If corrective action is recommended, the                                            Qualification Plan/Report, Assay     Contractor must address, in writing, concerns                             Technical      Validation Plan/Report, Assay        raised by BARDA in writing                09.1                            Documents       Technology Transfer Report, Batch                                            Records, SOPs, Master Production                                            Records, Certificate of Analysis,                                            Clinical Studies Data or Reports. The                                            CO and COR reserve the right to                                            request within the PoP a non-                                            proprietary technical document for                                            distribution within the Government                                                                                 Contractor shall provide a draft package                                            Contractor shall provide Animal                                            Model or Other Technology Transfer   within 20 business days of COR or CO                                            Package containing relevant          request                          Animal Model or                                            methodology and data sufficient to   Contractor shall revise the package to                09.2     Other Technology                                            enable other practitioners in the field address BARDA’s concerns,                         Transfer Package                                            to successfully replicate experimental recommendations and/or requests for                                            conditions developed and tested with additional detail                                            BARDA support                                            Contractor shall provide raw data or  Contractor shall provide raw data or data                         Raw Data or Data                09.3                        data analysis to BARDA upon request  analysis to CO and COR within 20 business                             Analysis                                                                                 days of request                                            Any manuscript or scientific meeting  Contractor must submit all manuscript or                                            abstract containing data generated    scientific meeting abstract to PO and CO                                            under this contract must be submitted prior to submission/presentation by 30                                            to BARDA for review prior to          business days for manuscripts and 15                                            submission. Acknowledgment of         business days for abstracts or posters                09.4        Publications                                            BARDA funding must be included as     Contractor must address in writing all                                            noted in contract articles H.9 and H.24 concerns raised by BARDA in writing                                                                                  Final submissions shall be submitted to                                                                                  BARDA concurrently or no later than one                                                                                  (1) calendar day of its submission                            Regulatory                                                      10                            Documents                                                                                                       Page 21 of 51  ACTIVE/104412070.3    





 






                                               Contract No. 75A50120C00034 Development of an mRNA Vaccine for SARS-CoV-2  CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND REPLACED WITH “[***]”. SUCH IDENTIFIED INFORMATION HAS BEEN   EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF DISCLOSED.                                               The Contractor shall memorialize any  Contractor shall provide copies of any FDA                               FDA                10.1                        correspondence between Contractor    correspondence within 2 business days of                          Correspondence                                            and FDA and submit to BARDA          correspondence                                                                                 Contractor shall submit draft FDA                                                                                 submissions to BARDA at least 15 business                                            The Contractor shall provide BARDA   days prior to FDA submission                                            the opportunity to review and                                                                                 BARDA will provide feedback to Contractor                                            comment upon all draft submissions                                            before submission to the FDA.        within 10 business days of receipt                10.2     FDA Submissions    Contractor shall provide BARDA with  The Contractor must address, in writing, its                                            an electronic copy of the final FDA  consideration of all concerns raised by                                            submission. All documents shall be   BARDA prior to FDA submission                                            duly marked as either “Draft” or     Final FDA submissions shall be submitted to                                            “Final”                              BARDA concurrently or no later than 1                                                                                 calendar day of submission                                                                                  Contractor shall ensure that the CO has                                                                                  received and approved an advanced copy of                                                                                  any press release to this contract not less                                                                                  than 5 business days prior to the issuance of                                                                                  the press release                                            Contractor agrees to accurately and                                                                                  If corrective action is required, the             11            Press Releases   factually represent the work conducted                                                                                  Contractor agrees to accurately and factually                                            under this contract in all press releases                                                                                  represent the work conducted under this                                                                                  contract in all press releases                                                                                  Any final press releases shall be submitted                                                                                  to BARDA no later than one (1) calendar                                                                                  day prior to its release                 2. Detailed Description of Select Contract Deliverables                  A.  Monthly and Annual Progress Reports                In addition to those reports required by the other terms of this contract, the Contractor shall prepare and submit the following reports                in the manner stated below and in accordance with this Article F of this contract, and in the Statement of Work, attached to this                contract as Attachment 1 (SECTION J-List of Attachments).                      i.      Monthly Progress Report                            This report shall include a description of the activities during the reporting period, and the activities planned for the                            ensuing reporting period. The first reporting period consists of the first full month of performance plus any fractional                            part of the initial month. Thereafter, the reporting period shall consist of each calendar month.                              The Contractor shall submit a Monthly Progress Report according to the dates set forth in the summary table                            (“Summary of Contract Deliverables”) under this article. The progress report shall conform to the requirements set                            forth in the DELIVERIES Article in SECTION F of this contract.                              The format should include:                                      A cover page that includes the contract number and title; the type of report and period that it covers; the                                    Contractor’s name, address, telephone number, fax number, and e-mail address; and the date of submission;                                    SECTION I – EXECUTIVE SUMMARY                                   SECTION II - PROGRESS                                   SECTION II Part A: OVERALL PROGRESS - A description of overall progress.                                   SECTION II Part B: MANAGEMENT AND ADMINISTRATIVE UPDATE - A description of all meetings,                                     conference calls, etc. that have taken place during the reporting period. Include progress on administration                                     and management issues (e.g., evaluating, and managing subcontractor performance, and personnel changes).                                   SECTION II Part C: TECHNICAL PROGRESS - For each activity related to Gantt chart, document the                                     results of work completed and cost incurred during the period covered in relation to proposed progress, effort                                     and budget. The report shall be in sufficient detail to explain comprehensively the results achieved. The                                     description shall include pertinent data and/or graphs in sufficient detail to explain any significant results                                     achieved and preliminary conclusions resulting from analysis and scientific evaluation of data accumulated to                                                                                                     Page 22 of 51  ACTIVE/104412070.3    





 






                                               Contract No. 75A50120C00034 Development of an mRNA Vaccine for SARS-CoV-2  CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND REPLACED WITH “[***]”. SUCH IDENTIFIED INFORMATION HAS BEEN   EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF DISCLOSED.                                      date under the contract. The report shall include a description of problems encountered and proposed                                     corrective action; differences between planned and actual progress, why the differences have occurred and                                     what corrective actions are planned; preliminary conclusions resulting from analysis and scientific evaluation                                     of data accumulated to date under the project.                                    SECTION II Part D: PROPOSED WORK - A summary of work proposed related to Gantt chart for the next                                     reporting period and preprints/reprints of papers and abstracts.                                   SECTION III: Estimated and Actual Expenses.                                    a. This section of the report shall contain a narrative or table detailing whether there is a significant                                     discrepancy (>10%) at this time between the % of work completed and the cumulative costs incurred to date.                                     Monthly and actual expenses should be broken down to the appropriate WBS level.                                     b. This section of the report should also contain estimates for the Subcontractors’ expenses from the previous                                     month if the Subcontractor did not submit a bill in the previous month. If the subcontractor(s) was not                                     working or did not incur any costs in the previous month, then a statement to this effect should be included in                                     this report for those respective subcontractors.                            A Monthly Progress Report will not be required in the same month that the Annual Progress Report is submitted.                      ii.     Annual Progress Report                            This report shall include a summation of the results of the entire contract work for the period covered. Monthly                            Progress Reports shall not be submitted in the same month when an Annual Progress Report is due. Furthermore, an                            Annual Progress Report will not be required for the period when the Final Report is due.                            The first Annual Progress Report shall be submitted in accordance with the date set forth in the table (“Summary of                            Contract Deliverables”) under ARTICLE F.2. of this contract. The progress report shall conform to the requirements                            set forth in the DELIVERIES Article in SECTION F of this contract.                              Each Annual Progress Report shall include:                                      A Cover page that includes the contract number and title; the type of report and period that it covers; the                                     Contractor's name, address, telephone number, fax number, and email address; and the date of submission;                       SECTION I: EXECUTIVE SUMMARY - A brief overview of the work completed, and the major accomplishments                        achieved during the reporting period.                       SECTION II: PROGRESS                       SECTION II Part A: OVERALL PROGRESS - A description of overall progress.                       SECTION II Part B: MANAGEMENT AND ADMINISTRATIVE UPDATE - A high level summary of critical meetings,                        etc. that have taken place during the reporting period. Include progress on administration and management to critical factors                        of the project (e.g. regulatory compliance audits and key personnel changes).                       SECTION II Part C: TECHNICAL PROGRESS - A detailed description of the work performed structured to follow the                        activities and decision gates outlined at the Integrated Baseline Review and as described in the Integrated Master Plan. The                        Report should include a description of any problems (technical or financial) that occurred or were identified during the                        reporting period, and how these problems were resolved.                       SECTION II Part D: PROPOSED WORK - A summary of work proposed for the next year period to include an updated                        Gantt Chart.                       SECTION III: Estimated and Actual Expenses.                                     a. This section of the report shall contain a narrative or table detailing whether there were discrepancies                                     between estimated and actual expenses over the past year. Actual expenses should be broken down to the                                     appropriate WBS level. This section of the report should also contain estimates for outstanding costs for the                                     previous year which may have been incurred, but not yet billed.                                   Contractor also should include the following in the Annual Progress Report:                                     1.   Copies of manuscripts (published and unpublished), abstracts, and any protocols or methods developed                                        specifically under the contract during the reporting period; and                                   2.   A summary of any Subject Inventions per the requirements under FAR Clause 52.227-11.                        iii. Draft Final Report and Final Report                            These reports are to include a summation of the work performed and results obtained for the entire contract period of                            performance. This report shall be in sufficient detail to describe comprehensively the results achieved. The Draft Final                            Report and Final Report shall be submitted in accordance with the DELIVERIES Article in SECTION F of the                            contract. An Annual Progress Report will not be required for the period when the Final Report is due. The Draft Final                                                                                                       Page 23 of 51  ACTIVE/104412070.3    





 






                                               Contract No. 75A50120C00034 Development of an mRNA Vaccine for SARS-CoV-2  CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND REPLACED WITH “[***]”. SUCH IDENTIFIED INFORMATION HAS BEEN   EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF DISCLOSED.                             Report and the Final Report shall be submitted in accordance with the dates set forth in the table (“Summary of                            Contract Deliverables”) under ARTICLE F.2. of this contract. The report shall conform to the following format:                                     1. Cover page to include the contract number, contract title, performance period covered, Contractor's name                                       and address, telephone number, fax number, email address and submission date.                                     2.   SECTION I: EXECUTIVE SUMMARY - Summarize the purpose and scope of the contract effort                                        including a summary of the major accomplishments relative to the specific activities set forth in the                                        Statement of Work.                                     3.  SECTION II: RESULTS - A detailed description of the work performed related to WBS and Gantt chart,                                       the results obtained, and the impact of the results on the scientific and/or public health community                                       including a listing of all manuscripts (published and in preparation) and abstracts presented during the                                       entire period of performance and a summary of all inventions.                              Draft Final Report: The Contractor is required to submit the Draft Final Report to the Contracting Officer’s                            Representative and Contracting Officer. The Contracting Officer’s Representative and Contracting Officer will review the                            Draft Final Report and provide the Contractor with comments in accordance with the dates set forth in ARTICLE F.2.                            of this contract.                              Final Report: The Contractor will deliver the final version of the Final Report on or before the completion date of the                            contract. The final version shall include or address the COR’s and CO’s written comments on the draft report. Final                            Report shall be submitted on or before the completion date of the contract.                  iv.  Summary of Salient Results                                The Contractor shall submit, with the Final Report, a summary (not to exceed 200 words) of salient results achieved                              during the performance of the contract.                          v.    Audit Reports                              Within thirty (30) calendar days of an audit related to conformance to FDA regulations and guidance, including                              adherence to GLP, GMP, GCP guidelines, the Contractor shall provide copies of the audit report (so long as received                              from the FDA) and a plan for addressing areas of nonconformance to FDA regulations and guidelines for GLP, GMP,                              or GCP guidelines as identified in the final audit report.                          vi.   Other Technical Reports                              1.   Draft Report for Clinical and Non-Clinical Studies and Final Report for Clinical and Non-Clinical Studies                                      The clinical trial reports shall follow the format of International Conference on Harmonization document ICH                                     E3 “Guideline for Industry on Structure and Content of Clinical Study Reports”                                    Draft Final Report for Clinical and Non-Clinical Studies funded by this contract will be submitted to the                                     Contracting Officer’s Representative and Contracting Officer (CO) for review and comment within the time                                     frames set forth in the table (“Summary of Contract Deliverables”) under ARTICLE F.2.                                    Subcontractor prepared reports received by the Contractor shall be submitted to the Contracting Officer’s                                     Representative and Contracting Officer (CO) for review and comment as set forth by the table in this Article.                                     Contractor shall consider revising reports to address BARDA’s recommendations prior to FDA submission.                                    The Government shall provide written comments to the Draft Final Report for Clinical and Non-Clinical                                     Studies in accordance with the dates set forth by the table in this Article.                                    The comprehensive Final Report for Clinical and Non-Clinical Studies will be submitted to the Contracting                                     Officer and the Contracting Officer’s Representative set forth by the table in this Article.                              2.   Supplemental Technical Documents                                       Upon request, Contractor shall provide CO and COR with the following contract funded documents as                                     specified below but not limited to: Process Development Reports; Assay Qualification Plan/Report, Assay                                     Validation Plan/Report, Assay Technology Transfer Report, Batch Records, Contractor/Subcontractor                                     Standard Operating Procedures (SOP’s), Master Production Records, Certificate of Analysis, Clinical Studies                                     Data or Reports. The CO and COR reserve the right to request within the Period of Performance a non-                                     proprietary technical document for distribution within the USG. Contractor shall provide technical document                                     within 10 business days of CO or COR request. Contractor can request additional time on an as needed basis.                                     If edits are recommended, the Contractor must address, in writing, concerns raised by BARDA.                                                                                                      Page 24 of 51  ACTIVE/104412070.3    





 






                                               Contract No. 75A50120C00034 Development of an mRNA Vaccine for SARS-CoV-2  CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND REPLACED WITH “[***]”. SUCH IDENTIFIED INFORMATION HAS BEEN   EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF DISCLOSED.                   B.  Deliverables Arising from FDA  Correspondence                   i. FDA Meetings                    The Contractor shall forward the dates and times of any meeting with the FDA to BARDA and make arrangements for                    appropriate BARDA staff to attend the FDA meetings. BARDA staff shall include up to a maximum of four people.                               Contractor shall notify BARDA of upcoming FDA meeting within 24 hours of scheduling Type A, B or C meetings                              OR within 24 hours of meeting occurrence for ad hoc meetings.                            The Contractor shall forward initial Contractor and FDA-issued draft minutes and final minutes of any meeting with                              the FDA to BARDA within 5 business days of receipt. All documents shall be duly marked as either “Draft” or                              “Final.”                  ii. FDA Submissions                      The Contractor shall provide BARDA all documents submitted to the FDA.                    Contractor shall provide BARDA with an electronic copy of the final FDA submission. All documents shall be duly marked as                    either “Draft” or “Final.”                               When draft documents are submitted for BARDA review, BARDA will provide feedback to Contractor within 3                              business days of receipt.                            When BARDA reviews draft documents, the Contractor shall revise their documents to address BARDA’s written                             concerns and/or recommendations prior to FDA submission.                             Final FDA submissions shall be submitted to BARDA concurrently or no later than 1 calendar day of their submission                              to FDA.                  iii. FDA Audits                    In the event of an FDA inspection which occurs as a result of this contract and for the product, or for any other FDA inspection                    that has the reasonable potential to impact the performance of this contract, the Contractor shall provide the USG with an exact                    copy (non-redacted) of the FDA Form 483 and the Establishment Inspection Report (EIR) within five (5) business days after the                    Contractors receipt of those documents. The Contractor shall provide the COR and CO with copies of the plan for addressing                    areas of non-conformance to FDA regulations for GLP, GMP, or GCP guidelines as identified in the audit report, status updates                    during the plans execution and a copy of all final responses to the FDA. The Contractor shall also provide redacted copies of any                    FDA audits received from subcontractors that occur as a result of this contract or for this product. The Contractor shall make                    arrangements for BARDA representative(s) to be present during the final debrief by the regulatory inspector.                                Contractor shall notify CO and COR within 10 business days of a scheduled FDA audit or within 24 hours of an ad                               hoc site visit/audit if the FDA does not provide advanced notice.                             Contractor shall provide copies of any FDA audit report received from subcontractors that occur as a result of this                               contract or for this product within 5 business days of receiving correspondence from the FDA, Subcontractor, or                               third party.                             Within 10 business days of audit report, Contractor shall provide CO with a plan for addressing areas of                               nonconformance, if any are identified.                  iv.  Manufacturing Campaign Reports                     Contractor shall provide Manufacturing Campaign Reports to BARDA for review and comment prior to submission to FDA.                       The COR and CO reserve the right to request within the Period of Performance (PoP) a non-proprietary Manufacturing                     Campaign Report for distribution within the USG.                               Contractor will submit Manufacturing Campaign Reports at least 15 business days prior to FDA submission.                            If corrective action is recommended, Contractor shall address, in writing, the concerns raised by BARDA.                            Contractor shall revise the reports to address BARDA’s concerns and/or recommendations prior to FDA submission.                            Final FDA submission shall be submitted to BARDA concurrently or no later than 1 business day after submission to                              the FDA.                                                                                                       Page 25 of 51  ACTIVE/104412070.3    





 






                                               Contract No. 75A50120C00034 Development of an mRNA Vaccine for SARS-CoV-2  CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND REPLACED WITH “[***]”. SUCH IDENTIFIED INFORMATION HAS BEEN   EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF DISCLOSED.                  v. Other FDA Correspondence                     The Contractor shall memorialize any correspondence between Contractor and FDA and submit to BARDA. All documents                     shall be duly marked as either “Draft” or “Final.” Contractor shall provide written summary of any FDA correspondence within                     5 business days of correspondence.                   i. Risk Management Plan                       The Contractor shall provide a Risk Management Plan that outlines the impacts of each risk in relation to the cost, schedule, and                     performance objectives. The plan shall include risk mitigation strategies. Each risk mitigation strategy will capture how the                     corrective action will reduce impacts on cost, schedule and performance.                                  Due within 90 days of contract award                                Contractor provides updated Risk Management Plan in Monthly Progress Report                                BARDA shall provide Contractor with a written list of concerns in response plan submitted                                Contractor must address, in writing, all concerns raised by BARDA within 20 business days of Contractor’s                                 receipt of BARDA’s concerns.                                                                                                        Page 26 of 51  ACTIVE/104412070.3    





 






                                               Contract No. 75A50120C00034 Development of an mRNA Vaccine for SARS-CoV-2  CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND REPLACED WITH “[***]”. SUCH IDENTIFIED INFORMATION HAS BEEN   EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF DISCLOSED.              3. Contract WBS Milestones/Deliverables and Technical Deliverables           Work Breakdown Structure (WBS), Go/No Go Program Stage Gates Gantt Chart, Integrated Master Schedule           (IMS)           Work Breakdown Structure and Option Periods             [***]   [***]                                                             [***]   [***]                                                 [***]           [***]          [***]               [***]      [***]                                                                                    [***]         [***]                                              [***]         [***]         [***]             [***]      [***]                                                                                    [***]         [***]                                                        [***]         [***]                                                        [***]                [***]                                                     [***]                [***]      [***]                                                                                    [***]            [***]                                           [***]                 [***]                [***]                                       [***]                 [***]                [***]                                       [***]                 [***]                [***]                                       [***]                 [***]            [***]                                                     [***]            [***]                                                     [***]                [***]                                                     [***]                [***]                [***]                                                     [***]                [***]      [***]                                                                                    [***]         [***]                                                                [***]                                                    [***]                 [***]             [***]         [***]                                                                [***]                                                                  [***]                [***]             [***]         [***]                                                        [***]                [***]                                                     [***]                [***]                [***]                                                     [***]                [***]                [***]                                                     [***]                [***]       [***]                                                                                   [***]         [***]                                                        [***]                [***]                                       [***]         [***]                [***]                [***]                                                     [***]                [***]         [***]                                                        [***]                [***]                                                     [***]                [***]      [***]                                                                                    [***]         [***]                                                        [***]                [***]                                       [***]                 [***]         [***]                                                        [***]         [***]                                                        [***]                [***]                                       [***]                 [***]                [***]                                                     [***]                                     [***]                                                     [***]                [***]             [***]                [***]                                                     [***]                [***]                [***]                                                     [***]                [***]                [***]                                                     [***]                                    [***]                                                      [***]                [***]                                                                                                       Page 27 of 51  ACTIVE/104412070.3    





 






                                               Contract No. 75A50120C00034 Development of an mRNA Vaccine for SARS-CoV-2  CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND REPLACED WITH “[***]”. SUCH IDENTIFIED INFORMATION HAS BEEN   EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF DISCLOSED.                [***]                [***]                                                     [***]                [***]         [***]                                                                [***]                                                                  [***]                [***]             [***]                [***]                                                                   [***]             [***]         [***]                                                                [***]                                                    [***]                 [***]                     [***]                                                                  [***]                [***]                                 [***]                                                      [***]                [***]             [***]                [***]                                                     [***]                Integrated Program Gantt Chart           Gantt Chart of Moderna’s Proposal “Development of an mRNA Vaccine mRNA vaccine”            [***]                                                                                                        Page 28 of 51  ACTIVE/104412070.3    





 






                                               Contract No. 75A50120C00034 Development of an mRNA Vaccine for SARS-CoV-2  CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND REPLACED WITH “[***]”. SUCH IDENTIFIED INFORMATION HAS BEEN   EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF DISCLOSED.            Deliverables           The primary deliverable of this proposal is a licensed mRNA vaccine. In addition, the team, in partnership with BARDA, will also design a           plan to enhance Moderna’s ability to rapidly respond to a Coronavirus pandemic by leveraging our mRNA platform. Interim deliverables are           presented below.               WBS         Title                                           Deliverable                              [***]             1           mRNA Vaccine Development                                                                          1.1         Program Management                                                                                                                                            -Management Plans; Routine Reporting               1.1.1       Program and Alliance Management                                                        [***]                                                                           Deliverables             1.2         Nonclinical Toxicology                                                                            1.2.2       Safety                                                                                              1.2.2.1     Development and Reproductive Toxicology       - Final Study Report                     [***]             1.3         Nonclinical                                                                                       1.3.1       Model Development (reserved)                                                                        1.3.1.2     NHP Efficacy Study                            - Final Study Report                     [***]               1.3.1.3     Mouse Efficacy Study                          - Final Study Report                     [***]             1.4         Clinical                                                                                          1.4.2       Phase 2                                                                                                                 - Clinical Study Protocol                [***]               1.4.2.1    Phase 2 Safety and Immunogenicity Study                                                                         - Final Clinical Study Report            [***]             1.4.3        Phase 3                                                      1.4.3.1   Phase 3 Efficacy or Safety and Immunogenicity   - Clinical Study Protocol                [***]                                                                         - Final Clinical Study Report            [***]                                                                         - Clinical Study Protocol                [***]               1.4.3.2    Phase 3 Lot-to-Lot                                                                         - Final Clinical Study Report            [***]                                                                         - Clinical Study Protocol                [***]               1.4.3.3    Phase 3 Adolescents                                                                         - Final Clinical Study Report            [***]             1.5         Regulatory                                                                                        1.5.1       IND                                                           1.5.1.1    IND Filing                                     - NA                                                1.5.1.2    IND Maintenance                                - Record of FDA Communications           [***]             1.5.2       BLA                                                                                      [***]               1.5.2.1     BLA Submission                                - NA                                              1.6         CMC                                                                                               1.6.3       Pilot Scale Manufacturing                                                                                                                                        [***]               1.6.3.2     CTM Manufacture for P201                      - CoA for Clinical Lots               1.6.3.4     CTM Manufacture for P301                      - CoA for Clinical Lots                  [***]               1.6.3.6     CTM Manufacture for P302/P303                 - CoA for Clinical Lots                  [***]                                                                                                        Page 29 of 51  ACTIVE/104412070.3    





 






                                          Contract No. 75A50120C00034 Development of an mRNA Vaccine for SARS-CoV-2  CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND REPLACED WITH “[***]”. SUCH IDENTIFIED INFORMATION HAS BEEN   EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF DISCLOSED.               [***]   [***]                  [***]                   [***]                       [***]            [***]   [***]                                                                                         [***]                                                                                 [***]                    [***]            [***]                        [***]                     [***]                       [***]             [***]   [***]                                                                                                                                        [***]            [***]   [***]               [***]                                                  [***]                                                                     [***]            [***]   [***]              [***]                                                   [***]              [***]   [***]                                                                                 [***]   [***]              [***]                                                   [***]                                                                   [***]                                                                     [***]            [***]   [***]              [***]                                                   [***]             [***]                      [***]                       [***]                       [***]                    [***]              [***]   [***]                                                                                 [***]   [***]              [***]                       [***]                       [***]              [***]   [***]              [***]                       [***]                       [***]                                                                                            Page 30 of 51  ACTIVE/104412070.3    





 






                                               Contract No. 75A50120C00034 Development of an mRNA Vaccine for SARS-CoV-2  CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND REPLACED WITH “[***]”. SUCH IDENTIFIED INFORMATION HAS BEEN   EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF DISCLOSED.                 G.  CONTRACT ADMINISTRATION                    G.1     Contracting Officer                      The Contracting Officer (CO) is the only individual who can legally commit the Government to the expenditure of public funds.                    No person other than the Contracting Officer can make any changes to the terms, conditions, general provisions or other                    stipulations of this Contract.                      The Contracting Officer is the only individual with authority to act as agent of the Government under this Contract, with                    authority to (1) direct or negotiate any changes in the statement of work, (2) modify or extend the period of performance, (3)                    authorize reimbursement to the Contractor for any costs incurred during the performance of this Contract and/or (5) otherwise                    change any terms and conditions of this Contract.                      No information, other than that which may be contained in an authorized modification to this contract duly issued by the                    Contracting Officer, which may be received from any person employed by the United States Government, or otherwise, shall be                    considered grounds for deviation from any stipulation of this contract.                      Wendell Conyers – (202) 692-4784 – wendell.conyers@hhs.gov – Office No. 21K13                    Supervisory Contract Specialist Division of Contracts Management & Acquisition (CMA)                    Biomedical Advanced Research & Development Authority (BARDA)                      G.2     Contracting Officer’s Representative                      As delegated by the CO, the Contracting Officer’s Representative (COR) is responsible for: (1) monitoring the Contractor's                    technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer                    changes in requirements; (2) assisting the CO in interpreting the statement of work and any other technical performance                    requirements; (3) performing technical evaluation as required; (4) performing technical inspections required by this contract; and                    (5) assisting in the resolution of technical problems encountered during performance.                      Chuong Huynh – (202) 260-2177 – chuong.huynh@hhs.gov – Office No.                    Project Officer / COR for Development Activities                    Influenza and Emerging Infectious Diseases Division                    Biomedical Advanced Research & Development Authority (BARDA)                        G.3     Deliveries                      All deliveries of physical documents, shall be addressed in the following format:                                                    UPS/FedEx/USPS                     U.S. Department of Health & Human Services                     Insert Recipient’s Name                     HHS/ASPR/BARDA                     Insert Office Number – O’Neill House Office Building, 2nd Floor                     Washington, DC 20515                     Insert Recipient’s Telephone Number                        G.4     Invoicing Instructions                      Invoices for payment shall be submitted to the Contracting Officer and Contracting Officer’s Representative, as one (1) hard                    copy and one (1) electronic copy addressed in the format indicated in G.3, shall follow the detailed invoicing instructions listed in                    Section J, and include an SF-1034.                                  CO                        COR                  Alternate COR                  PSC                    Wendell Conyers (Contracting  Chuong Huynh (COR       TBD Alt COR                                  Officer)                      HHS/ASPR/BARDA          HHS/ASPR/BARDA                    HHS/ASPR/BARDA/CMA            O’Neill House Office    O’Neill House Office      PSC_Invoices@psc.hhs.go                    O’Neill House Office          Building                Building                  v                    Building                      Room Number             Room Number 24K13                            Room Number 21C06             24K24                   Washington, D.C.20515     &                    Washington, DC 20515          Washington, DC 20515    TBD                                          Email:                        TBD                                               “HHS e-Room” (shared                    wnedell.conyers@hhs.gov                                                         access may be provided to                                                                                                       Page 31 of 51  ACTIVE/104412070.3    





 






                                               Contract No. 75A50120C00034 Development of an mRNA Vaccine for SARS-CoV-2  CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND REPLACED WITH “[***]”. SUCH IDENTIFIED INFORMATION HAS BEEN   EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF DISCLOSED.                                                                           the Contractor after                                                                                                    award).                      a. Contractor invoices/financial reports shall conform to the form, format, and content requirements of the                      instructions for Invoice/Financing requests and Contract Financial Reporting.                      b. Monthly invoices must include the cumulative total expenses to date, adjusted (as applicable) to show any                    amounts suspended by the Government.                      c. The Contractor agrees to immediately notify the CO in writing if there is an anticipated overrun (any amount) or                    unexpended balance (greater than 10%) of the estimated costs for the base period or any option period(s) (See estimated                    costs under Section B) and the reasons for the variance. These requirements are in addition to the specified requirements of                    FAR 52.232-20, Limitation of Cost that is incorporated by reference under Section I.1 which states;                         Limitation of Cost (Apr 1984)                               The parties estimate that performance of this contract, exclusive of any fee, will not cost the Government more                    than (1) the estimated cost specified in the Schedule or, (2) if this is a cost-sharing contract, the Government’s share of the                    estimated cost specified in the Schedule. The Contractor agrees to use its best efforts to perform the work specified in the                    Schedule and all obligations under this contract within the estimated cost, which, if this is a cost-sharing contract, includes                    both the Government’s and the Contractor’s share of the cost.             The Contractor shall notify the Contracting Officer in writing whenever it has reason to believe that—                               The costs the Contractor expects to incur under this contract in the next 60 days, when added to all costs           previously incurred, will exceed 75 percent of the estimated cost specified in the Schedule; or                               The total cost for the performance of this contract, exclusive of any fee, will be either greater or substantially           less than had been previously estimated.                               As part of the notification, the Contractor shall provide the Contracting Officer a revised estimate of the total           cost of performing this contract. Except as required by other provisions of this contract, specifically citing and stated to be an           exception to this clause—             •               The Government is not obligated to reimburse the Contractor for costs incurred in excess of (i) the estimated cost           specified in the Schedule or, (ii) if this is a cost-sharing contract, the estimated cost to the Government specified in the Schedule; and             •               The Contractor is not obligated to continue performance under this contract (including actions under the Termination           clause of this contract) or otherwise incur costs in excess of the estimated cost specified in the Schedule, until the Contracting Officer (i)           notifies the Contractor in writing that the estimated cost has been increased and (ii) provides a revised estimated total cost of performing           this contract. If this is a cost-sharing contract, the increase shall be allocated in accordance with the formula specified in the Schedule.             •               No notice, communication, or representation in any form other than that specified in paragraph (d)(2) of this clause, or           from any person other than the Contracting Officer, shall affect this contract’s estimated cost to the Government. In the absence of the           specified notice, the Government is not obligated to reimburse the Contractor for any costs in excess of the estimated cost or, if this is a           cost-sharing contract, for any costs in excess of the estimated cost to the Government specified in the Schedule, whether those excess           costs were incurred during the course of the contract or as a result of termination.             •              If the estimated cost specified in the Schedule is increased, any costs the Contractor incurs before the increase that are           in excess of the previously estimated cost shall be allowable to the same extent as if incurred afterward, unless the Contracting Officer           issues a termination or other notice directing that the increase is solely to cover termination or other specified expenses.             •               Change orders shall not be considered an authorization to exceed the estimated cost to the Government specified in the           Schedule, unless they contain a statement increasing the estimated cost.             •               If this contract is terminated or the estimated cost is not increased, the Government and the Contractor shall           negotiate an equitable distribution of all property produced or purchased under the contract, based upon the share of costs incurred by           each.                     d. The Contractor shall submit an electronic copy of the payment request to the approving official instead of a paper copy.                   The payment request shall be transmitted as an attachment via e-mail to the address listed above in one of the following                   formats: MSWord, MS Excel, or Adobe Portable Document Format (PDF). Only one payment request shall be submitted per                   e-mail and the subject line of the e-mail shall include the Contractor's name, contract number, and unique invoice number.                             e.  An electronic copy of the payment request shall be uploaded into the designated eRoom (as defined in Section F.3                                                                                                       Page 32 of 51  ACTIVE/104412070.3    





 






                                               Contract No. 75A50120C00034 Development of an mRNA Vaccine for SARS-CoV-2  CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND REPLACED WITH “[***]”. SUCH IDENTIFIED INFORMATION HAS BEEN   EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF DISCLOSED.                                Electronic Submission) and an e-mail notification of the upload will be provided to the CO and COR.                             f.  All invoice submissions shall be in accordance with FAR 52.232-25, Prompt Payment (Oct 2008).                           g.  Invoices - Cost and Personnel Reporting, and Variances from the Negotiated Budget.                             h.  Invoices - Cost and Personnel Reporting, and Variances from the Negotiated Budget.                      The Contractor agrees to provide a detailed breakdown on invoices of the following cost categories:                                  1.  Direct Labor - List individuals by name, title/position, hourly/annual rate, level of effort (actual hours or %                                    of effort), and amount claimed.                                2.  Fringe Benefits - Cite rate and amount                                3.  Overhead - Cite rate and amount                                4.  Materials & Supplies - Include detailed breakdown when total amount is over $100,000                                5.  Travel - Identify travelers, dates, destination, purpose of trip, and total breaking out amounts for                                    transportation (plane, car, etc.), lodging, M&IE. Cite COA, if appropriate. List separately, domestic travel,                                    general scientific meeting travel, and foreign travel.                                6.  Consultant Fees - Identify individuals, amounts and activities. Cite appropriate COA                                7.  Subcontracts - Attach subcontractor invoice(s). Cite appropriate COA                                8.  Equipment - Cite authorization and amount. Cite appropriate COA                                9.  Other Direct Costs - Include detailed breakdown when total amount is over $100,000.                                10. G&A - Cite rate and amount.                                11. Total Cost (and applicable cost-shared ratio)                                12. Fixed Fee (if applicable)                                13. Total Cost Plus Fixed Fee                      Monthly invoices must include the cumulative total expenses to date, adjusted (as applicable) to show any amounts                    suspended by the USG. Nothing inthis section  discharges the contractor's responsibility to comply with any applicable                    FAR Parts 30 or 31 clauses' relating to cost reimbursement subcontracts. In order to verify allowability, further                    breakdown of costs may be requested at the USG's discretion. The Contractor shall subcontract with Firm Fixed Price                    Contracts to the maximum extent practicable.                      Additional instructions and an invoice template are provided in Section J-List of Attachments, Invoice/Financing Request                    Instructions and Contract Financial Reporting Instructions for Cost- Reimbursement Contracts. All invoices must be signed by                    a representative of the contractor authorized to certify listed charges are accurate and comply with government regulations.                    Invoices shall be signed and submitted electronically (in accordance with Section F.3 Electronic Submission).                      If applicable, the Contractor shall convert any foreign currency amount(s) in the monthly invoice to U.S. dollars each month,                    on the 1st of the month, using the foreign exchange rate index published on www.federalreserve.gov. Payment of invoices is                    subject to the U.S. dollar limits within the Total Costs of CLIN 0001 and 0002 in Section B of the contract.                      The Government shall use electronic funds transfer to the maximum extent possible when making payments under this contract.                    FAR 52.232-33, Payment by Electronic Funds Transfer–System for Award Management, in Section I requires the Contractor to                    designate in writing a financial institution for receipt of electronic funds transfer payments.                              The electronic version of the invoice can be submitted via e-mail or uploaded through HHS’ eRoom (shared access                    may be provided to the Contractor after award).                      The Government may request additional information (timecards, receipts, etc.) to support costs claimed in the Contractor’s                    invoices. Incomplete invoices may be suspended by the Contracting Officer if the Contractor’s claimed costs cannot be                    substantiated.                      G.5      REIMBURSEMENT OF COST                          The Government shall reimburse the Contractor the cost determined by the Contracting Officer to be allowable (hereinafter                        referred to as allowable cost) in accordance with FAR 52.216-7, Allowable Cost and Payment incorporated by reference in                        Section I, Contract Clauses, of this contract, and FAR Subpart 31.2. Examples of allowable costs include, but are not limited                        to, the following:                          a)  All direct materials and supplies that are used in performing the work provided for under the contract, including those                        purchased for subcontracts and purchase orders.                          b)  All direct labor, including supervisory, that is properly chargeable directly to the contract, plus fringe benefits.                                                                                                      Page 33 of 51  ACTIVE/104412070.3    





 






                                               Contract No. 75A50120C00034 Development of an mRNA Vaccine for SARS-CoV-2  CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND REPLACED WITH “[***]”. SUCH IDENTIFIED INFORMATION HAS BEEN   EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF DISCLOSED.                           c)  All other items of cost budgeted for and accepted in the negotiation of this basic contract or modifications thereto.                          d)  Travel costs including per diem or actual subsistence for personnel while in an actual travel status in direct performance                        of the work and services required under this contract subject to the following:                          (i) Air travel shall be by the most direct route using “air coach” or “air tourist” (less than first class or business class)                        unless it is clearly unreasonable or impractical (e.g., not available for reasons other than avoidable delay in making                        reservations, would require circuitous routing or entail additional expense offsetting the savings on fare, or would not make                        necessary connections).                          (ii) Rail travel shall be by the most direct route, first class with lower berth or nearest equivalent.                          (iii) Costs incurred for lodging, meals, and incidental expenses shall be considered reasonable and allowable to the extent                        that they do not exceed on a daily basis the per diem rates set forth in the Federal Travel Regulation (FTR).                          (iv) Travel via privately owned automobile shall be reimbursed at not more than the current General Services                        Administration (GSA) FTR established mileage rate.                        G.6     Providing Accelerated Payment to Small Business Subcontractors, FAR 52.232-40 (Dec. 2013)                      (a) Upon receipt of accelerated payments from the Government, the Contractor shall make accelerated payments to its small                        business subcontractors under this contract, to the maximum extent practicable and prior to when such payment is otherwise                        required under the applicable contract or subcontract, after receipt of a proper invoice and all other required documentation                        from the small business subcontractor.                    (b) The acceleration of payments under this clause does not provide any new rights under the prompt Payment Act.                    (c) Include the substance of this clause, include this paragraph c, in all subcontracts with small business concerns, including                        subcontracts with small business concerns for the acquisition of commercial items.                      G.7     Contract Communication/Correspondence             The Contractor shall identify all correspondence, reports, and other data pertinent to this contract by imprinting thereon the contract           number from Page 1 of the contract.                     [***]                               3.       In accordance with FAR Part 5.216-7(d), the contractor shall submit an adequate final indirect cost rates                                    proposal to the contracting officer within the 6-months period following the end of its fiscal years during the                                    period of contract performance                        G.8     Post-Award Evaluation of Contractor Performance                      (a) Purpose: In accordance with FAR 42.1502(a), past performance evaluations shall be prepared at least annually and at the                        time the work under a contract or order is completed, via CPARS, the Government-wide evaluation tool (www.cpars.gov).                      (b) Evaluators: The performance evaluation will be completed jointly by the Contracting                        Officer’s Representative and the Contracting Officer.                      (c) Performance Evaluation Factors: Per FAR 42.1503(b)(2), evaluation factors for each assessment shall include, at a                        minimum: technical (quality of product or service); cost control; schedule/timeliness; management and business relations;                        small business subcontracting; other (as applicable).                      (d) Contractor Review: A copy of the evaluation will be electronically sent to the Contractor as soon as practicable after                        completion of the evaluation. The Contractor shall submit comments, rebutting statements, or additional information to the                        Contracting Officer within 14 calendar days after receipt of the evaluation.                      (e) Resolving Disagreements between the Government and the Contractor: Disagreements between the parties regarding the                        evaluation will be reviewed at a level above the Contracting Officer. The ultimate conclusion on the performance evaluation                        is a decision of the contracting agency. Copies of the evaluation, Contractor's response, and review comments, if any, will be                        retained as part of the evaluation.                                                                                                      Page 34 of 51  ACTIVE/104412070.3    





 






                                               Contract No. 75A50120C00034 Development of an mRNA Vaccine for SARS-CoV-2  CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND REPLACED WITH “[***]”. SUCH IDENTIFIED INFORMATION HAS BEEN   EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF DISCLOSED.                       (f) Release of Contractor Performance Evaluation Information: The completed evaluation will not be released to other than                        Government personnel and the Contractor whose performance is being evaluated. Disclosure of such information could                        cause harm both to the commercial interest of the Government and to the competitive position of the Contractor being                        evaluated, as well as impede the efficiency of Government operations.                      (g) Source Selection Information: Departments and agencies may share past performance information with other Government                        departments and agencies when requested to support future award decisions. The information may be provided through                        interview and/or by sending the evaluation and comment document to the requesting source selection official.                      (h) Retention Period: The agency will retain past performance information for a maximum period of 3 years after completion of                        contract performance for the purpose of providing source selection information for future contract awards.                                                                                                        Page 35 of 51  ACTIVE/104412070.3    





 






                                               Contract No. 75A50120C00034 Development of an mRNA Vaccine for SARS-CoV-2  CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND REPLACED WITH “[***]”. SUCH IDENTIFIED INFORMATION HAS BEEN   EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF DISCLOSED.                 H.  SPECIAL CONTRACT REQUIREMENTS                      H.1     Access and Disposition of Data                      The Government shall have physical and electronic access to all documentation and data generated under this contract, including:                    all Contractor efforts; Subcontractor efforts; communications and correspondence with regulatory agencies and bodies to include                    all audit observations, inspection reports, meeting minutes, and all Contractor commitments and responses.                      H.2     Interactions with the Food and Drug Administration (FDA)                      The Contractor shall memorialize any interactions between the Contractor and the FDA, and submit documentation to the COR                    and CO. All documents shall be duly marked as either “Draft” or “Final.”                          H.2.1    FDA Correspondence                        Contractor shall provide written summary of any FDA correspondence within five (5) business days of correspondence.                          H.2.2    FDA Meetings                        The Contractor shall forward the dates and times of any meeting with the FDA to the COR and CO, and make arrangements                        for appropriate BARDA staff to attend the FDA meetings. BARDA staff shall include up to a maximum of four people                        (COR, CO and up to 2 subject matter experts).                                   (1)     Contractor shall notify the COR and CO of upcoming FDA meeting within 24 hours of scheduling Type                                         A, B or C meetings, or within 24 hours of meeting occurrence for ad hoc meetings.                                 (2)     The Contractor shall forward initial Contractor and FDA-issued draft and final minutes of any meeting                                         with the FDA, to the COR and CO, within 2 business days of receipt. All documents shall be duly                                         marked as either “Draft” or “Final.”                          H.2.3    FDA Pre-Submissions, Submissions, and Other Related Correspondence                        The Contractor shall provide the COR and CO the opportunity to review and comment upon all draft submissions directly                        related to this contract before submission to the FDA. Contractor shall provide the COR and CO with an electronic copy of                        the final FDA submission. All documents shall be duly marked as either “Draft” or “Final”.                                   (1)     Contractor shall submit draft FDA submissions to the COR and CO at least 15 business days prior to                                         FDA submission.                                 (2)     The COR and CO will provide feedback to Contractor within 5 business days of receipt.                                 (3)     If corrective action is recommended, the Contractor must address, in writing, its consideration of all                                         concerns raised by the COR and CO.                                 (4)     The Contractor shall consider revising their documents to address the COR and CO’s concerns and/or                                         recommendations prior to FDA submission.                                 (5)     Final FDA submissions shall be submitted to the COR and CO concurrently or no later than 1 calendar                                         day of its submission to FDA                          H.2.4    FDA Audits                        In the event of an FDA inspection which occurs as a result of this contract and for the product, or for any other FDA                        inspection that has the reasonable potential to impact the performance of this contract, the Contractor shall provide the USG                        with an exact copy (non-redacted) of the FDA Form 483 and the Establishment Inspection Report (EIR). The Contractor                        shall provide the COR and CO with copies of the plan for addressing areas of non-conformance to FDA regulations for                        GLP, GMP, or GCP guidelines as identified in the audit report, status updates during the plans execution and a copy of all                        final responses to the FDA. The Contractor shall also provide redacted copies of any FDA audits received from                        subcontractors that occur as a result of this contract or for this product. The Contractor shall make arrangements for BARDA                        representative(s) to be present during the final debrief by the regulatory inspector.                                   (1)     Contractor shall notify CO and COR within 10 business days of a scheduled FDA audit or within 24                                         hours of an ad hoc site visit/audit if the FDA does not provide advanced notice.                                 (2)     Contractor shall provide copies of any FDA audit report received from subcontractors that occur as a                                         result of this contract or for this product within 5 business days of receiving correspondence from the                                         FDA or third party.                                 (3)     Within 10 business days of audit report, Contractor shall provide CO and COR with a plan for                                         addressing areas of nonconformance, if any are identified.                      H.3     Key Personnel             Pursuant to HHSAR 352.237-75 (Dec 2015), Key Personnel, any key personnel specified in this contract are considered to be essential to           work performance. At least thirty (30) calendar days prior to the Contractor voluntarily diverting any of the specified individuals to other           programs or contracts the Contractor shall notify the Contracting Officer and shall submit a justification for the diversion or replacement           and a request to replace the individual. The request must identify the proposed replacement and provide an explanation of how the                                                                                                      Page 36 of 51  ACTIVE/104412070.3    





 






                                               Contract No. 75A50120C00034 Development of an mRNA Vaccine for SARS-CoV-2  CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND REPLACED WITH “[***]”. SUCH IDENTIFIED INFORMATION HAS BEEN   EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF DISCLOSED.            replacement's skills, experience, and credentials meet or exceed the requirements of the contract (including, when applicable, Human           Subjects Testing requirements). If the employee of the Contractor is terminated for cause or separates from the Contractor voluntarily with           less than thirty (30) calendar-day notice, the Contractor shall provide the maximum notice practicable under the circumstances. The           Contractor shall not divert, replace, or announce any such change to key personnel without the written consent of the Contracting Officer.           The contract will be modified to add or delete key personnel as necessary to reflect the agreement of the parties. The following individuals           are determined to be key personnel:                 [***]                                    [***]                             [***]              [***]                             [***]               [***][***]              [***]                             [***]               [***]              [***]                             [***]               [***]              [***]                             [***]               [***]              [***]                             [***]               [***]              [***]                             [***]               [***]              [***]                             [***]               [***]              [***]                             [***]               [***]                           H.3.1        Personnel Qualifications                            The Contractor shall provide curriculum vitae (CV) for each individual identified as key personnel. The CV shall                            clearly describe the individual’s knowledge, work experiences, registrations, and certifications, and applicable                            experience. The CV shall include a summary describing the individual’s involvement in similar work.                      H.4     Substitution of Key Personnel                          a.       The Contractor agrees to assign to the contract those persons whose resumes/CVs were submitted with the                                 proposal who are necessary to fill the requirements of the contract. No substitutions shall be made except in                                 accordance with this clause.                        b.       All requests for substitution must provide a detailed explanation of the circumstance necessitating the proposed                                 substitution, a complete resume for the proposed substitute and any other information requested by the contracting                                 officer to approve or disapprove the proposed substitution. All proposed substitutes must have qualifications that                                 are equal to or higher than the qualifications of the person to be replaced. The contracting officer or authorized                                 representative will evaluate such requests and promptly notify the contractor of his approval or disapproval                                 thereof.                        c.       The contractor further agrees to include the substance of this clause in any subcontract, which may be awarded                                 under this contract.                      H.5     Contracting Officer’s Authorization (COA) for Subcontracting             The Contractor shall submit a Contracting Officer’s Authorization (COA) approval request, to the Contracting Officer, for all           subcontractors, consultants and equipment purchases proposed during the course of this contract. COAs for subcontractors and consultant           agreements shall be submitting when the potential subcontract is expected to exceed $150,000; for equipment purchases, when the unit           price per item is expected to exceed $25,000. Sufficient time shall be provided for the Government to fully assess the transaction proposed.           The supporting documents shall include, but not be limited to:                          1.       Competition activities, as well as technical and cost/price evaluation activities performed, in the selection of the                                 subcontractor(s);                        2.       The subcontractor’s qualifications/capabilities statement as they pertain to the activities included in the proposed                                 subcontract;                        3.       The subcontractor’s willingness to perform under the Contractor (i.e. commitment letters/preliminary agreements),                                 with a list of specific duties included in the proposed subcontract;                        4.       A complete subcontractor cost proposal or quote, in similar format as the Contractor’s cost proposal.                                                                                                        Page 37 of 51  ACTIVE/104412070.3    





 






                                               Contract No. 75A50120C00034 Development of an mRNA Vaccine for SARS-CoV-2  CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND REPLACED WITH “[***]”. SUCH IDENTIFIED INFORMATION HAS BEEN   EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF DISCLOSED.                     H.6     No Personal Services or Inherently Governmental Function             Pursuant to FAR 37.1, no personal services shall be performed under this contract. All work requirements shall flow only from the COR to           the Contractor's Project Manager. No Contractor employee will be directly supervised by the Government. All employee assignments, and           daily work direction, shall be given by the applicable Contractor supervisor. If the Contractor believes any Government action or           communication has been given that would create a personal services relationship between the Government and any Contractor employee,           the Contractor shall promptly notify the Contracting Officer of this communication or action.             Pursuant to FAR 7.5, the Contractor shall not perform any inherently governmental actions under this contract. No Contractor employee           shall hold him or herself out to be a Government employee, agent, or representative. No Contractor employee shall state orally or in writing           at any time that he or she is acting on behalf of the Government. In all communications with third parties in connection with this contract,           Contractor employees shall identify themselves as Contractor employees and specify the name of the company for which they work. In all           communications with other Government Contractors in connection with this contract, the Contractor employee shall state that they have no           authority to in any way change this contract and that if the other Contractor believes this communication to be a direction to change their           contract, they shall notify the Contracting Officer for that contract and not carry out the direction until a clarification has been issued by the           Contracting Officer.             The Contractor shall ensure that all of its employees working on this contract are informed of the substance of this article. Nothing in this           article shall limit the Government’s rights in any way under the other provisions of this contract, including those related to the           Government’s right to inspect and accept the services to be performed under this contract. The substance of this article shall be included in           all subcontracts at any tier.                      H.7     Acknowledgement of Federal Funding – Publication and Publicity             The Contractor shall acknowledge the support of the Department of Health and Human Services, Office of the Assistant Secretary for           Preparedness and Response, Biomedical Advanced Research and Development Authority whenever publicizing the work under this           contract in any media by including an acknowledgment substantially as follows:             "This project has been funded in whole or in part with Federal funds from the Office of the Assistant Secretary for Preparedness and           Response, Biomedical Advanced Research and Development Authority, under Contract No. 75A50120C00034."             Press Releases:             The Contractor shall clearly state, when issuing statements, press releases, requests for proposals, bid solicitations and other documents           describing projects or programs funded in whole or in part with Federal money: (1) the percentage of the total costs of the program or           project which will be financed with Federal money; (2) the dollar amount of Federal funds for the project or program; and (3) the           percentage and dollar amount of the total costs of the project or program that will be financed by nongovernmental sources.                      H.8     352.270-4b, Protection of Human Subjects (Dec 2015)             (a) The Contractor agrees that the rights and welfare of human subjects involved in research under this contract shall be protected in           accordance with 45 CFR part 46 and with the Contractor’s current Federal-wide Assurance (FWA) on file with the Office for Human           Research Protections (OHRP), Department of Health and Human Services. The Contractor further agrees to provide certification at least           annually that the Institutional Review Board has reviewed and approved the procedures, which involve human subjects in accordance with           45 CFR part 46 and the Assurance of Compliance.             (b) The Contractor shall bear full responsibility for the performance of all work and services involving the use of human subjects under this           contract and shall ensure that work is conducted in a proper manner and as safely as is feasible. The parties hereto agree that the Contractor           retains the right to control and direct the performance of all work under this contract. Nothing in this contract shall create an agency or           employee relationship between the Government and the Contractor, or any subcontractor, agent or employee of the Contractor, or any other           person, organization, institution, or group of any kind whatsoever. The Contractor agrees that it has entered into this contract and will           discharge its obligations, duties, and undertakings and the work pursuant thereto, whether requiring professional judgment or otherwise, as           an independent Contractor without creating liability on the part of the Government for the acts of the Contractor or its employees.             (c) Contractors involving other agencies or institutions in activities considered to be engaged in research involving human subjects must           ensure that such other agencies or institutions obtain their own FWA if they are routinely engaged in research involving human subjects or           ensure that such agencies or institutions are covered by the Contractors’ FWA via designation as agents of the institution or via individual           investigator agreements (see OHRP website at: http://www.hhs.gov/ohrp/policy/guidanceonalternativetofwa.pdf).             (d) If at any time during the performance of this contract the Contractor is not in compliance with any of the requirements and or standards           stated in paragraphs (a) and (b) above, the Contracting Officer may immediately suspend, in whole or in part, work and further payments           under this contract until the Contractor corrects the noncompliance. The Contracting Officer may communicate the notice of suspension by           telephone with confirmation in writing. If the Contractor fails to complete corrective action within the period of time designated in the           Contracting Officer’s written notice of suspension, the Contracting Officer may, after consultation with OHRP, terminate this contract in           whole or in part.                                                                 (End of clause)                                                                                                      Page 38 of 51  ACTIVE/104412070.3    





 






                                               Contract No. 75A50120C00034 Development of an mRNA Vaccine for SARS-CoV-2  CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND REPLACED WITH “[***]”. SUCH IDENTIFIED INFORMATION HAS BEEN   EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF DISCLOSED.                       H.9     HHSAR 352.270-5a, Notice to Offerors of Requirement for Compliance with the Public Health Service Policy on                    Humane Care and Use of Laboratory Animals (Dec 2015)                      The Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals (PHS Policy) establishes a number of                    requirements for research activities involving animals. Before awarding a contract to an offeror, the organization shall file, with                    the Office of Laboratory Animal Welfare (OLAW), National Institutes of Health (NIH), a written Animal Welfare Assurance                    (Assurance) which commits the organization to comply with the provisions of the PHS Policy, the Animal Welfare Act, and the                    Guide for the Care and Use of Laboratory Animals (National Academy Press, Washington, DC). In accordance with the PHS                    Policy, offerors must establish an Institutional Animal Care and Use Committee (IACUC), qualified through the experience and                    expertise of its members, to oversee the institution’s animal program, facilities, and procedures. Offerors must provide                    verification of IACUC approval prior to receiving an award involving live vertebrate animals. No award involving the use of                    animals shall be made unless OLAW approves the Assurance and verification of IACUC approval for the proposed animal                    activities has been provided to the Contracting Officer. Prior to award, the Contracting Officer will notify Contractor(s) selected                    for projects involving live vertebrate animals of the Assurance and verification of IACUC approval requirement. The Contracting                    Officer will request that OLAW negotiate an acceptable Assurance with those Contractor(s) and request verification of IACUC                    approval. For further information, contact OLAW at NIH, 6705 Rockledge Drive, RKL1, Suite 360, MSC 7982 Bethesda,                    Maryland 20892-7982 (E-mail: olaw@od.nih.gov; Phone: 301–496–7163).                                                                 (End of provision)                        H.10    HHSAR 352.270-5b, Care of Life Vertebrate Animals (Dec 2015)                      (a) Before undertaking performance of any contract involving animal-related activities where the species is regulated by the                    United Sates Department of Agriculture (USDA), the Contractor shall register with the Secretary of Agriculture of the United                    States in accordance with 7 U.S.C. 2136 and 9 CFR 2.25 through 2.28. The Contractor shall furnish evidence of the registration                    to the Contracting Officer.                      (b) The Contractor shall acquire vertebrate animals used in research from a dealer licensed by the Secretary of Agriculture under                    7 U.S.C. 2133 and 9 CFR 2.1 2.11, or from a source that is exempt from licensing under those sections.                      (c) The Contractor agrees that the care, use, and intended use of any live vertebrate animals in the performance of this contract                    shall conform with the Public Health Service (PHS) Policy on Humane Care of Use of Laboratory Animals (PHS Policy), the                    current Animal Welfare Assurance (Assurance), the Guide for the Care and Use of Laboratory Animals (National Academy                    Press, Washington, DC) and the pertinent laws and regulations of the United States Department of Agriculture (see 7 U.S.C. 2131                    et seq. and 9 CFR subchapter A, Parts 1-4). In case of conflict between standards, the more stringent standard shall govern.                      (d) If at any time during performance of this contract, the Contracting Officer determines, in consultation with the Office of                    Laboratory Animal Welfare (OLAW), National Institutes of Health (NIH), that the Contractor is not in compliance with any of                    the requirements and standards stated in paragraphs (a) through (c) above, the Contracting Officer may immediately suspend, in                    whole or in part, work and further payments under this contract until the Contractor corrects the noncompliance. Notice of the                    suspension may be communicated by telephone and confirmed in writing. If the Contractor fails to complete corrective action                    within the period of time designated in the Contracting Officer's written notice of suspension, the Contracting Officer may, in                    consultation with OLAW, NIH, terminate this contract in whole or in part, and the Contractor's name may be removed from the                    list of those contractors with Animal Welfare Assurances.                      Note: The Contractor may request registration of its facility and a current listing of licensed dealers from the Regional Office of                    the Animal and Plant Health Inspection Service (APHIS), USDA, for the region in which its research facility is located. The                    location of the appropriate APHIS Regional Office, as well as information concerning this program may be obtained by                    contacting the Animal Care Staff, USDA/APHIS, 4700 River Road, Riverdale, Maryland 20737 (Email: ace@aphis.usda.gov;                    Web site: http://www.aphis.usda.gov/wps/portal/aphis/ourfocus/animalwelfare)                                                                   (End of clause)                      H.11    Animal Welfare                      All research involving live, vertebrate animals shall be conducted in accordance with the Public Health Service Policy on                    Humane Care and Use of Laboratory Animals (PHS Policy). The PHS Policy can be accessed at:                    http://grants1.nih.gov/grants/olaw/references/phspol.htm                      H.12    Dissemination of False or Deliberately Misleading Information                      The Contractor shall not use contract funds to disseminate information that is deliberately false or misleading.                                                                                                       Page 39 of 51  ACTIVE/104412070.3    





 






                                               Contract No. 75A50120C00034 Development of an mRNA Vaccine for SARS-CoV-2  CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND REPLACED WITH “[***]”. SUCH IDENTIFIED INFORMATION HAS BEEN   EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF DISCLOSED.                     H.13    Electronic Information and Technology Accessibility Notice             a.   Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998 and the                Architectural and Transportation Barriers Compliance Board Electronic and Information (EIT) Accessibility Standards (36 CFR part                1194), require that when Federal agencies develop, procure, maintain, or use electronic and information technology, Federal                employees with disabilities have access to and use of information and data that is comparable to the access and use by Federal                employees who are not individuals with disabilities, unless an undue burden would be imposed on the agency. Section 508 also                requires that individuals with disabilities, who are members of the public seeking information or services from a Federal agency, have                access to and use of information and data that is comparable to that provided to the public who are not individuals with disabilities,                unless an undue burden would be imposed on the agency.             b.   Accordingly, any Offeror responding to this solicitation must comply with established HHS EIT accessibility standards. Information                about Section 508 is available at http://www.hhs.gov/web/508. The complete text of the Section 508 Final Provisions can be accessed                at http://www.access-board.gov/sec508/standards.htm.             c.   The Section 508 accessibility standards applicable to this solicitation are stated in the clause at 352.239-74, Electronic and Information                Technology Accessibility.                  In order to facilitate the Government's determination whether proposed EIT supplies meet applicable Section 508 accessibility                standards, Offerors must submit an HHS Section 508 Product Assessment Template, in accordance with its completion instructions.                The purpose of the template is to assist HHS acquisition and program officials in determining whether proposed EIT supplies conform                to applicable Section 508 accessibility standards. The template allows                Offerors or developers to self-evaluate their supplies and document--in detail--whether they conform to a specific Section 508                accessibility standard, and any underway remediation efforts addressing conformance issues. Instructions for preparing the HHS                Section 508 Evaluation Template are available under Section 508 policy on the HHS Web site http://hhs.gov/web/508.                  In order to facilitate the Government's determination whether proposed EIT services meet applicable Section 508 accessibility                standards, Offerors must provide enough information to assist the Government in determining that the EIT services conform to                Section 508 accessibility standards, including any underway remediation efforts addressing conformance issues.             d.   Respondents to this solicitation must identify any exception to Section 508 requirements. If a Offeror claims its supplies or services                meet applicable Section 508 accessibility standards, and it is later determined by the Government, i.e., after award of a contract or                order, that supplies or services delivered do not conform to the described accessibility standards, remediation of the supplies or                services to the level of conformance specified in the contract will be the responsibility of the Contractor at its expense.                    (End of provision)                      H.14    Confidentiality of Information             a.   Confidential information, as used in this article, means information or data of a personal nature about an individual, or proprietary                information or data submitted by or pertaining to an institution or organization.             b.   The Contracting Officer and the Contractor may, by mutual consent, identify elsewhere in this contract specific information and/or                categories of information which the Government will furnish to the Contractor or that the Contractor is expected to generate which is                confidential. Similarly, the Contracting Officer and the Contractor may, by mutual consent, identify such confidential information                from time to time during the performance of the contract. Failure to agree will be settled pursuant to the "Disputes" clause.             c.   If it is established elsewhere in this contract that information to be utilized under this contract, or a portion thereof, is subject to the                Privacy Act, the Contractor will follow the rules and procedures of disclosure set forth in the Privacy Act of 1974, 5 U.S.C. 552a, and                implementing regulations and policies, with respect to systems of records determined to be subject to the Privacy Act.             d.   Confidential information, as defined in paragraph (a) of this article, shall not be disclosed without the prior written consent of the                individual, institution, or organization.             e.   Whenever the Contractor is uncertain with regard to the proper handling of material under the contract, or if the material in question is                subject to the Privacy Act or is confidential information subject to the provisions of this article, the Contractor shall obtain a written                determination from the Contracting Officer prior to any release, disclosure, dissemination, or publication.             f.   Contracting Officer Determinations will reflect the result of internal coordination with appropriate program and legal officials.             g.   The provisions of paragraph (d) of this article shall not apply to conflicting or overlapping provisions in other Federal, State or local                laws.                    H.15    Institutional Responsibility Regarding Investigator Conflicts of Interest                      The Institution (includes any Contractor, public or private, excluding a Federal agency) shall comply with the requirements of 45                    CFR Part 94, Responsible Prospective Contractors, which promotes objectivity in research by establishing standards to ensure                    that Investigators (defined as the project director or principal Investigator and any other person, regardless of title or position,                                                                                                      Page 40 of 51  ACTIVE/104412070.3    





 






                                               Contract No. 75A50120C00034 Development of an mRNA Vaccine for SARS-CoV-2  CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND REPLACED WITH “[***]”. SUCH IDENTIFIED INFORMATION HAS BEEN   EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF DISCLOSED.                     who is responsible for the design, conduct, or reporting of research funded under BARDA contracts, or proposed for such                    funding, which may include, for example, collaborators or consultants) will not be biased by any Investigator financial conflicts                    of interest. 45 CFR Part 94 is available at the following Web site: http://www.ecfr.gov/cgi-                    bin/textidx?c=ecfr&SID=0af84ca649a74846f102aaf664da1623&rgn=div5&view=text&node=45:1.0.1.1.51&idno=45                      As required by 45 CFR Part 94, the Institution shall, at a minimum:                              a.   Maintain an up-to-date, written, enforceable policy on financial conflicts of interest that complies with 45 CFR                                 Part 94, inform each Investigator of the policy, the Investigator's reporting responsibilities regarding disclosure of                                 significant financial interests, and the applicable regulation, and make such policy available via a publicly                                 accessible Web site, or if none currently exist, available to any requestor within five business days of a request. A                                 significant financial interest means a financial interest consisting of one or more of the following interests of the                                 Investigator (and those of the Investigator's spouse and dependent children) that reasonably appears to be related                                 to the Investigator's institutional responsibilities:                                       1.  With regard to any publicly traded entity, a significant financial interest exists if the value of any                                         remuneration received from the entity in the twelve months preceding the disclosure and the value of                                         any equity interest in the entity as of the date of disclosure, when aggregated, exceeds $5,000. Included                                         are payments and equity interests;                                     2.  With regard to any non-publicly traded entity, a significant financial interest exists if the value of any                                         remuneration received from the entity in the twelve months preceding the disclosure, when aggregated,                                         exceeds $5,000, or when the Investigator (or the Investigator's spouse or dependent children) holds any                                         equity interest; or                                     3.  Intellectual property rights and interests, upon receipt of income related to such rights and interest.                                   Significant financial interests do not include the following:                                       1.  Income from seminars, lectures, or teaching, and service on advisory or review panels for G agencies,                                         Institutions of higher education, academic teaching hospitals, medical centers, or research institutes with                                         an Institution of higher learning; and                                     2.  Income from investment vehicles, such as mutual funds and retirement accounts, as long as the                                         Investigator does not directly control the investment decisions made in these vehicles.                              b.   Require each Investigator to complete training regarding the Institution's financial conflicts of interest policy prior                                 to engaging in research related to any BARDA funded contract and at least every four years. The Institution must                                 take reasonable steps [see Part 94.4(c)] to ensure that investigators working as collaborators, consultants or                                 subcontractors comply with the regulations.                              c.   Designate an official(s) to solicit and review disclosures of significant financial interests from each Investigator                                 who is planning to participate in, or is participating in, the BARDA funded research.                              d.   Require that each Investigator who is planning to participate in the BARDA funded research disclose to the                                 Institution's designated official(s) the Investigator's significant financial interest (and those of the Investigator's                                 spouse and dependent children) no later than the date of submission of the Institution's proposal for BARDA                                 funded research. Require that each Investigator who is participating in the BARDA funded research to submit an                                 updated disclosure of significant financial interests at least annually, in accordance with the specific time period                                 prescribed by the Institution during the period of the award as well as within thirty days of discovering or                                 acquiring a new significant financial interest.                              e.   Provide guidelines consistent with the regulations for the designated official(s) to determine whether an                                 Investigator's significant financial interest is related to BARDA funded research and, if so related, whether the                                 significant financial interest is a financial conflict of interest. An Investigator's significant financial interest is                                 related to BARDA funded research when the Institution, thorough its designated official(s), reasonably determines                                 that the significant financial interest: Could be affected by the BARDA funded research; or is in an entity whose                                 financial interest could be affected by the research. A financial conflict of interest exists when the Institution,                                 through its designated official(s), reasonably determines that the significant financial interest could directly and                                 significantly affect the design, conduct, or reporting of the BARDA funded research.                              f.   Take such actions as necessary to manage financial conflicts of interest, including any financial conflicts of a                                 subcontractor Investigator. Management of an identified financial conflict of interest requires development and                                 implementation of a management plan and, if necessary, a retrospective review and mitigation report pursuant to                                 Part 94.5(a).                              g.   Provide initial and ongoing FCOI reports to the Contracting Officer pursuant to Part 94.5(b).                                                                                                       Page 41 of 51  ACTIVE/104412070.3    





 






                                               Contract No. 75A50120C00034 Development of an mRNA Vaccine for SARS-CoV-2  CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND REPLACED WITH “[***]”. SUCH IDENTIFIED INFORMATION HAS BEEN   EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF DISCLOSED.                             h.   Maintain records relating to all Investigator disclosures of financial interests and the Institution's review of, and                                 response to, such disclosures, and all actions under the Institution's policy or retrospective review, if applicable,                                 for at least 3 years from the date of final payment or, where applicable, for the other time periods specified in 48                                 CFR Part 4, subpart 4.7, Contract Records Retention.                              i.   Establish adequate enforcement mechanisms and provide for employee sanctions or other administrative actions to                                 ensure Investigator compliance as appropriate.                              j.   Complete the certification in Section K - Representations, Certifications, and Other Statements of Contractors                                 titled "Certification of Institutional Policy on Financial Conflicts of Interest".                      If the failure of an Institution to comply with an Institution's financial conflicts of interest policy or a financial conflict of interest                    management plan appears to have biased the design, conduct, or reporting of the BARDA funded research, the Institution must                    promptly notify the Contracting Officer of the corrective action taken or to be taken. The Contracting Officer will consider the                    situation and, as necessary, take appropriate action or refer the matter to the Institution for further action, which may include                    directions to the Institution on how to maintain appropriate objectivity in the BARDA funded research project.                      The Contracting Officer and/or HHS may inquire at any time before, during, or after award into any Investigator disclosure of                    financial interests, and the Institution's review of, and response to, such disclosure, regardless of whether the disclosure resulted                    in the Institution's determination of a financial conflict of interests. The Contracting Officer may require submission of the                    records or review them on site. On the basis of this review of records or other information that may be available, the Contracting                    Officer may decide that a particular financial conflict of interest will bias the objectivity of the BARDA funded research to such                    an extent that further corrective action is needed or that the Institution has not managed the financial conflict of interest in                    accordance with Part 94.6(b). The issuance of a Stop Work Order by the Contracting Officer may be necessary until the matter is                    resolved.                      If the Contracting Officer determines that BARDA funded clinical research, whose purpose is to evaluate the safety or                    effectiveness of a drug, medical device, or treatment, has been designed, conducted, or reported by an Investigator with a                    financial conflict of interest that was not managed or reported by the Institution, the Institution shall require the Investigator                    involved to disclose the financial conflict of interest in each public presentation of the results of the research and to request an                    addendum to previously published presentations.                      H.16    Reporting Matters Involving Fraud, Waste and Abuse                      Anyone who becomes aware of the existence or apparent existence of fraud, waste and abuse in BARDA funded programs is                    encouraged to report such matters to the HHS Inspector General's Office in writing or on the Inspector General's Hotline. The toll                    free number is 1-800-HHS-TIPS (1-800-447-8477). All telephone calls will be handled confidentially. The e-mail address is                    Htips@os.dhhs.gov and the mailing address is:                      Office of Inspector General                    Department of Health and Human Services                    TIPS HOTLINE                    P.O. Box 23489                    Washington, D.C. 20026                      H.17    Prohibition on Contractor Involvement with Terrorist Activities                      The Contractor acknowledges that U.S. Executive Orders and Laws, including but not limited to E.O. 13224 and Pub. L. 107-56,                    prohibit transactions with, and the provision of resources and support to, individuals and organizations associated with terrorism.                    It is the legal responsibility of the Contractor to ensure compliance with these Executive Orders and Laws. This clause must be                    included in all subcontracts issued under this contract.                      H.18    FAR 52.227-14, Rights in Data – General (May 2014), Alternate II (December 2007)                      As prescribed in FAR 27.409(b)(3), the following paragraph is inserted into (g)(3) of the basic clause:                      (g)(3) Notwithstanding paragraph (g)(1) of this clause, the contract may identify and specify the delivery of limited rights data, or                    the Contracting Officer may require by written request the delivery of limited rights data that has been withheld or would                    otherwise be entitled to be withheld. If delivery of that data is required, the Contractor shall affix the following “Limited Rights                    Notice” to the data and the Government will treat the data, subject to the provisions of paragraphs (e) and (f) of this clause, in                    accordance with the notice:                                                        Limited Rights Notice (Dec 2007)                      (a) These data are submitted with limited rights under Government Contract No. 75A50120C00034 and subcontracts. These data                    may be reproduced and used by the Government with the express limitation that they will not, without written permission of the                    Contractor, be used for purposes of manufacture nor disclosed outside the Government; except that the Government may disclose                                                                                                      Page 42 of 51  ACTIVE/104412070.3    





 






                                               Contract No. 75A50120C00034 Development of an mRNA Vaccine for SARS-CoV-2  CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND REPLACED WITH “[***]”. SUCH IDENTIFIED INFORMATION HAS BEEN   EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF DISCLOSED.                     these data outside the Government for the following purposes, if any; provided that the Government makes such disclosure                    subject to prohibition against further use and disclosure:                      (i) Use (except for manufacture) by support service.                      (b) This notice shall be marked on any reproduction of these data, in whole or in part.                                                                   (End of notice)                                                                                                        Page 43 of 51  ACTIVE/104412070.3    





 






                                               Contract No. 75A50120C00034 Development of an mRNA Vaccine for SARS-CoV-2  CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND REPLACED WITH “[***]”. SUCH IDENTIFIED INFORMATION HAS BEEN   EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF DISCLOSED.            PART II – CONTRACT CLAUSES                  I.  CONTRACT CLAUSES                      I.1     52.252-2 Clauses Incorporated by Reference (Feb 1998)             This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request,           the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this address:           http://acquisition.gov/far/             The following FAR clauses, pertinent to Section I, are hereby incorporated by reference:               FAR Clause         Title                                                                                  Date             52.202-1           Definitions                                                                            Nov 2013             52.203-3           Gratuities                                                                             Apr 1984             52.203-5           Covenant Against Contingent Fees                                                       May 2014             52.203-6           Restrictions on Subcontractor Sales to the Government                                  Sep 2006             52.203-7           Anti-Kickback Procedures                                                               May 2014             52.203-8           Cancellation, Rescission, and Recovery of Funds for Illegal or Improper Activity       May 2014              52.203-10          Price or Fee Adjustment for Illegal or Improper Activity                               May 2014             52.203-12          Limitation on Payments to Influence Certain Federal Transactions                       Oct 2010             52.203-13          Contractor Code of Business Ethics and Conduct                                         Oct 2015             52.203-14          Display of Hotline Poster(s)                                                           Oct 2015             52.203-17          Contractor Employee Whistleblower Rights and Requirement To Inform Employees of        Apr 2014                                Whistleblower Rights             52.203-19          Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements     Jan 2017              52.204-1           Administrative Matters Provisions and Clauses                                          Dec 1989             52.204-4           Printed or Copied Double-Sided on Postconsumer Fiber Content Paper                     May 2011             52.204-7                   System for Award Management                                                    Oct 2018             52.204-10          Reporting Executive Compensation and First-Tier Subcontract Awards                     Oct 2018             52.204-13          System for Award Management Maintenance                                                Oct 2018             52.204-16          Commercial and Government Entity Code Reporting                                        Jul 2016             52.204-17          Ownership of Control or Offeror                                                        Jul 2016             52.204-18          Commercial and Government Entity Code Maintenance                                      Jul 2016             52.204-19          Incorporation by Reference of Representations and Certifications                       Dec 2014             52.204-23          Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Jul 2018                                Kaspersky Lab and Other Covered Entities             52.209-5           Certification Regarding Responsibility Matters                                         Oct 2015              52.209-6           Protecting the Government's Interests When Subcontracting With Contractors Debarred,   Oct 2015                                Suspended, or Proposed for Debarment             52.209-9           Updates of Publicly Available Information Regarding Responsibility Matters             Oct 2018              52.209-10          Prohibition on Contracting with Inverted Domestic Corporations                         Nov 2015             52.210-1           Market Research                                                                        Apr 2011             52.215-2           Audit and Records – Negotiation                                                        Oct 2010             52.215-8           Order of Precedence - Uniform Contract Format                                          Oct 1997             52.215-10          Price Reduction for Defective Cost or Pricing Data                                     Aug 2011             52.215-11          Price Reduction for Defective Certified Cost or Pricing Data—Modifications.            Aug 2011              52.215-12          Subcontractor Certified Cost or Pricing Data                                           Oct 2010                                                                                                       Page 44 of 51  ACTIVE/104412070.3    





 






                                               Contract No. 75A50120C00034 Development of an mRNA Vaccine for SARS-CoV-2  CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND REPLACED WITH “[***]”. SUCH IDENTIFIED INFORMATION HAS BEEN   EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF DISCLOSED.                52.215-13          Subcontractor Certified Cost or Pricing Data—Modifications                             Oct 2010             52.215-14          Integrity of Unit Prices (Over SAT)                                                    Oct 2010             52.215-15          Pension Adjustments and Asset Reversions                                               Oct 2010             52.215-18          Reversion or Adjustment of Plans for Postretirement Benefits (PRB) other than Pensions Jul 2005              52.215-19          Notification of Ownership Changes                                                      Oct 1997             52.215-20          Requirements for Certified Cost or Pricing Data and Data Other Than Certified Cost or Pricing Oct 2010                                Data)             52.215-21          Requirements for Certified Cost or Pricing Data and Data Other Than Certified Cost or Pricing Oct 2010                                Data -Modifications             52.215-22          Limitations on Pass-Through Charges—Identification of Subcontract Effort               Oct 2009             52.215-23          Limitations on Pass-Through Charges                                                    Oct 2009             52.216-7           Allowable Cost and Payment                                                             Aug 2018                          52.216-8           Fixed Fee                                                                              Jun 2011             52.217-8           Option to Extend Services [within thirty (30) calendar days from contract expiration.] Nov 1999             52.219-8           Utilization of Small Business Concerns                                                 Oct 2018                                       52.219-28          Post-Award Small Business Program Representation                                       July 2013             52.222-1           Notice to the Government of Labor Disputes                                             Feb 1997             52.222-2           Payment for Overtime Premiums [*$0.00]                                                 July 1990             52.222-3           Convict Labor                                                                          Jun2003             52.222-21          Prohibition of Segregated Facilities                                                   Apr 2015             52.222-24          Pre-award On-Site Equal Opportunity Compliance Evaluation                              Feb 1999             52.222-26          Equal Opportunity                                                                      Sept 2016             52.222-35          Equal Opportunity for Veterans ($150,000 or more)                                      Oct 2015             52.222-36          Equal Opportunity for Workers with Disabilities                                        Jul 2014             52.222-37          Employment Reports on Veterans                                                         Feb 2016             52.222-38          Compliance with Veterans’ Employment Reporting Requirements                            Feb 2016             52.222-40          Notification of Employee Rights Under the National Labor Relations Act                 Dec 2010             52.222-50          Combating Trafficking in Persons                                                       Jan 2019             52.222-54          Employment Eligibility Verification                                                    Oct 2015             52.223-6           Drug-Free Workplace                                                                    May 2001             52.223-18          Encouraging Contractor Policy to Ban Text Messaging While Driving                      Aug 2011             52.224-1           Privacy Act Notification                                                               April 1984             52.224-2           Privacy Act                                                                            April 1984             52.224-3           Privacy Training                                                                       Jan 2017             52.225-13          Restrictions on Certain Foreign Purchases                                              Jun 2008             52.225-25          Prohibition on Contracting with Entities Engaging in Certain Activities or Transactions Relating Aug 2018                                to Iran—Representation and Certifications             52.227-1           Authorization and Consent                                                              Dec 2007             52.227-2           Notice and Assistance Regarding Patent and Copyright Infringement                      Dec 2007             52.227-11          Patent Rights-Ownership by the Contractor                                              May 2014             52.227-14          Rights in Data – General                                                               May 2014             52.227-14          Rights in Data – General, Alternate II (Dec 2007)                                      May 2014             52.228-7           Insurance – Liability to Third Persons                                                 Mar 1996             52.232-9           Limitation on Withholding of Payments                                                  Apr 1984                                                                                                       Page 45 of 51  ACTIVE/104412070.3    





 






                                               Contract No. 75A50120C00034 Development of an mRNA Vaccine for SARS-CoV-2  CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND REPLACED WITH “[***]”. SUCH IDENTIFIED INFORMATION HAS BEEN   EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF DISCLOSED.                52.232-17          Interest                                                                               May 2014             52.232-20          Limitation of Cost                                                                     Apr 1984             52.232-23          Assignment of Claims                                                                   May 2014             52.232-25          Prompt Payment Alt I                                                                   Jan 2017             52.232-33          Payment by Electronic Funds Transfer--System for Award Management                      Oct 2018             52.232-39          Unenforceability of Unauthorized Obligations                                           Jun 2013             52.232-40          Providing Accelerated Payments to Small Business Subcontractors                        Dec 2013             52.233-1           Disputes                                                                               May 2014             52.233-3           Protest After Award, Alternate I (Jun 1985)                                            Aug 1996             52.233-4           Applicable Law for Breach of Contract Claim                                            Oct 2004             52.242-1           Notice of Intent to Disallow Costs                                                     Apr 1984             52.242-3           Penalties for Unallowable Costs                                                        May 2014             52.242-4           Certification of Final Indirect Costs                                                  Jan 1997             52.242-13          Bankruptcy                                                                             Jul 1995             52.243-2           Changes—Cost-Reimbursement, Alternate I (Apr 1984)                                     Apr 1984             52.243-2           Changes—Cost-Reimbursement, Alternate V (Apr 1984)                                     Aug 1987             52.243-6           Change Order Accounting                                                                Apr 1984             52.243-7           Notification of Changes                                                                Jan 2017             52.244-2           Subcontracts, Alternate I (Jun 2007)                                                   Oct 2010             52.244-5           Competition in Subcontracting                                                          Dec 1996             52.244-6           Subcontracts for Commercial Items                                                      Jan 2019             52.245-1           Government Property                                                                    Jan 2017             52.245-9           Use and Charges                                                                        Apr 2012             52.246-25          Limitation of Liability—Services                                                       Feb 1997             52.249-6           Termination (Cost-Reimbursement)                                                       May 2004             52.249-14          Excusable Delays                                                                       Apr 1984             52.253-1           Computer Generated Forms                                                               Jan 1991                       I.2     Department of Health and Human Services Acquisition Regulation (HHSAR) Clauses             Full text of HHSAR clauses may be accessed electronically at this address: http://www.hhs.gov/grants/contracts/contract-policies-           regulations/hhsar                                                                                                                                     HHSAR Clause       Title                                                                                  Date              352.203-70         Anti-Lobbying                                                                          Dec 2015             352.208-70         Printing and Duplication                                                               Dec 2015             352.222-70         Contractor Cooperation in Equal Employment Opportunity Investigations                  Dec 2015             352.223-70         Safety and Health                                                                      Dec 2015             352.224-71         Confidential Information                                                               Dec 2016             352.227-70         Publications and Publicity                                                             Dec 2015             352.231-70         Salary Rate Limitation                                                                 Dec 2015             352.233-71         Litigation and Claims                                                                  Dec 2015             352.237-75         Key Personnel                                                                          Dec 2015             352.239-74         Electronic and Information Technology Accessibility                                    Dec 2015             352.270-9          Non-discrimination for Conscience                                                      Dec 2015                                                                                                        Page 46 of 51  ACTIVE/104412070.3    





 






                                               Contract No. 75A50120C00034 Development of an mRNA Vaccine for SARS-CoV-2  CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND REPLACED WITH “[***]”. SUCH IDENTIFIED INFORMATION HAS BEEN   EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF DISCLOSED.                       I.3     Additional Contract Clauses                          I.3.1        Additional Federal Acquisition Regulation (FAR) Clauses in Full Text                                 52.217-9 Option to Extend the Term of the Contract (Mar 2000)                            (a) The Government may extend the term of this contract by written notice to the Contractor within thirty (30) calendar                            days; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least                            thirty (30) days before the contract expires. The preliminary notice does not commit the Government to an extension.                              (b) If the Government exercises this option, the extended contract shall be considered to include this option clause.                              (c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed five 5)                            years and six (6) months.                                                                           (End of Clause)                              52.203-18 Prohibition on Contracting with Entities that Require Certain Internal Confidentiality Agreements or                            Statements--Representation (Jan 2017)                            a)   Definition. As used in this provision—                            “Internal confidentiality agreement or statement”, “subcontract”, and “subcontractor”, are defined in the clause at                            52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements.                              b)   In accordance with section 743 of Division E, Title VII, of the Consolidated and Further Continuing                                 Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as                                 extended in continuing resolutions), Government agencies are not permitted to use funds appropriated (or                                 otherwise made available) for contracts with an entity that requires employees or subcontractors of such entity                                 seeking to report waste, fraud, or abuse to sign internal confidentiality agreements or statements prohibiting or                                 otherwise restricting such employees or subcontractors from lawfully reporting such waste, fraud, or abuse to a                                 designated investigative or law enforcement representative of a Federal department or agency authorized to                                 receive such information.                              c)   The prohibition in paragraph (b) of this provision does not contravene requirements applicable to Standard Form                                 312, (Classified Information Nondisclosure Agreement), Form 4414 (Sensitive Compartmented Information                                 Nondisclosure Agreement), or any other form issued by a Federal department or agency governing the                                 nondisclosure of classified information.                              d)   Representation. By submission of its offer, the Offeror represents that it will not require its employees or                                 subcontractors to sign or comply with internal confidentiality agreements or statements prohibiting or otherwise                                 restricting such employees or subcontractors from lawfully reporting waste, fraud, or abuse related to the                                 performance of a Government contract to a designated investigative or law enforcement representative of a                                 Federal department or agency authorized to receive such information (e.g., agency Office of the Inspector                                 General).                                                                 (End of provision)                              52.222-35 Equal Opportunity Veterans (Oct 2015)                            a)   Definitions. As used in this clause—                                   “Active duty wartime or campaign badge veteran,” “Armed Forces service medal veteran,” “disabled veteran,”                                 “protected veteran,” “qualified disabled veteran,’ and “recently separated veteran” have the meanings given at                                 FAR 22.1301.                              b)   Equal opportunity clause. The Contractor shall abide by the requirements of the equal opportunity clause at 41                                 CFR 60-300.5(a), as of March 24, 2014. This clause prohibits discrimination against qualified protected veterans,                                 and requires affirmative action by the Contractor to employ and advance in employment qualified protected                                 veterans.                              c)   Subcontracts. The Contractor shall insert the terms of this clause in subcontracts of $150,000 or more unless                                 exempted by rules, regulations, or orders of the Secretary of Labor. The Contractor shall act as specified by the                                 Director, Office of Federal Contract Compliance Programs, to enforce the terms, including action for                                 noncompliance. Such necessary changes in language may be made as shall be appropriate of identify properly the                                 parties and their undertakings.                                                                 (End of Clause)                                                                                                      Page 47 of 51  ACTIVE/104412070.3    





 






                                                Contract No. 75A50120C00034 Development of an mRNA Vaccine for SARS-CoV-2  CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND REPLACED WITH “[***]”. SUCH IDENTIFIED INFORMATION HAS  BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF   DISCLOSED.                                52.222-36 Equal Opportunity for Workers with Disabilities (Jul 2014)                             a)   Equal opportunity clause. The Contractor shall abide by the requirements of the equal opportunity                                  clause at 41 CFR 60.741.5(a), as of March 24, 2014. This clause prohibits discrimination against                                  qualified individuals on the basis of disability, and requires affirmative action by the Contractor to                                  employ and advance in employment qualified individuals with disabilities.                               b)   Subcontracts. The Contractor shall include the terms of this clause in every subcontract or purchase                                  order in excess of $15,000 unless exempted by rules, regulations, or orders of the Secretary, so that such                                  provisions will be binding upon each subcontractor or vendor. The Contractor shall act as specified by                                  the Director, Office of Federal Contract Compliance Programs of the U.S. Department of Labor, to                                  enforce the terms, including action for noncompliance. Such necessary changes in language may be                                  made as shall be appropriate to identify properly the parties and their undertakings.                                                             (End of Clause)              PART III – LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS                  J.   LIST OF ATTACHMENTS                            Attachment 2: INVOICING INSTRUCTIONS FOR COST REIMBURSEMENT CONTRACTS                        Attachment 3: SAMPLE INVOICE/PAYMENT REQUEST AND CONTRACT FINANCIAL REPORT                        Attachment 4: FINANCIAL REPORT OF INDIVIDUAL PROJECT/CONTRACT                        Attachment 5: INSTRUCTION FOR COMPLETING FINANCIAL REPORT OF INDIVIDUAL PROJECT/CONTRACT                        Attachment 6: INCLUSION ENROLLMENT REPORT                        Attachment 7: RESEARCH PATIENT CARE COSTS                        Attachment 8: CONTRACTING SITE – CONTRACT NUMBER – INVENTORY SHEET                        Attachment 9: DISCLOSURE OF LOBBYING ACTIVITIES                        Attachment 10: DATA ITEM DESCRIPTION                        Attachment 11: SEVEN PRINCIPLES OF EARNED VALUE MANAGEMENT  LITE                                                                                                                                                                           Page 48 of 51  ACTIVE/104412070.3    





 






                                                                                   Contract No. 75A50120C00034 Development of an mRNA Vaccine for SARS-CoV-2  CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND REPLACED WITH “[***]”. SUCH IDENTIFIED INFORMATION HAS  BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF   DISCLOSED.                                                                                                                                                                                                                                                                                                                                                                                                                                                 2. AMENDMENT/MODIFICATION NO.                                     3. EFFECTIVE DATE                              4. REQUISITION/PURCHASE REQ. NO.                               5. PROJECT NO. (If applicable)                                                                                                                             P00002                                                            See Block 16C      6. ISSUED BY                                            CODE      ASPR-BARDA                                     7. ADMINISTERED BY (If other than Item 6)                      CODE ASPR-BARDA02      ASPR-BARDA                                                                                                       US DEPT OF HEALTH & HUMAN SERVICES                                                                                                                                                                                                                                                                                                                                                                                                      8. NAME AND ADDRESS OF CONTRACTOR (No., street, county, State and ZIP Code)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               75A50120C00034                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         11.  THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS                                                                                                                                                                                                   The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers                                               is extended,         is not extended.         Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended , by one of the following methods: (a) By completing        Items 8 and 15, and returning                            copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted ; or (c) By        separate letter or electronic communication which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGEMENT TO BE        RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR        OFFER. If by virtue of this amendment you desire to change an offer already submitted , such change may be made by letter or electronic communication, provided        each letter or electronic communication makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.                                                                                                                                                                     12. ACCOUNTING AND APPROPRIATION DATA (If required)     See Schedule                                                                                                                                                                                                                                                                                                       13.  THIS ITEM ONLY APPLIES TO MODIFICATION OF CONTRACTS/ORDERS. IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.          CHECK ONE        A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT                           ORDER NO. IN ITEM 10A.                              B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office,                           appropriation data, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).                         C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:                         D. OTHER (Specify type of modification and authority)            X           FAR 43.103(a)                                                                                                                                                                                                                                                 E. IMPORTANT:            Contractor                    is not       x is required to sign this document and return                             1        copies to the issuing office.                                                                                                                                                                                                                                                                                                        14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)     [***]     [***]      The purpose of this modification is to add the revised Statement of Work (SOW) dated June     3, 2020 to Option CLIN 0003. The CLIN value remains unchanged at $53,000,000.                                                                                                           All other     contract terms and conditions remain unchanged.        Except as provided herein, all terms and conditions of the document referenced in Item 9 A or 10A, as heretofore changed, remains unchanged and in full force and effect .      15A. NAME AND TITLE OF SIGNER (Type or print)                                                                     16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)                                                                                                                              [***]                                                                                                              WENDELL CONYERS      15B. CONTRACTOR/OFFEROR                                                             15C. DATE SIGNED              16B. UNITED STATES OF AMERICA                                                 16C. DATE SIGNED                                                                                                                                                                                                                                                                                                                                  [***]                                                                                                                                                                                               06/16/2020                      (Signature of person authorized to sign)                                                                              (Signature of Contracting Officer)       Previous edition unusable                                                                                                                                                   STANDARD FORM 30 (REV. 11/2016)                                                                                                                                                                                 PagePrescribed 49 byof GSA 51 FAR (48 CFR) 53.243  ACTIVE/104412070.3    





 






                                                Contract No. 75A50120C00034 Development of an mRNA Vaccine for SARS-CoV-2  CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND REPLACED WITH “[***]”. SUCH IDENTIFIED INFORMATION HAS  BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF   DISCLOSED.                                                Continuation Page                                                                                                                                                                                                                 Contract Number: 75A50120C00034                                                                                                                        Development of an mRNA Vaccine for SARS-CoV-2                                                          Option 1 Statement of Work                                                                  Dated June 3, 2020                [***]                                          [***]                  [***]                                          [***]                                                                                                                            CONFIDENTIAL                                                                                                       Page 50 of 51  ACTIVE/104412070.3    





 






                                               Contract No. 75A50120C00034 Development of an mRNA Vaccine for SARS-CoV-2  CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND REPLACED WITH “[***]”. SUCH IDENTIFIED INFORMATION HAS BEEN   EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF DISCLOSED.                                                                                              200 Tech Square • Cambridge, MA 02139 phone                                                                                                             617-714-6500 • fax 617-583-1998                                                                                                                                                         [***]                [***]                [***]                [***]                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 2                                                                                                      Page 51 of 51  ACTIVE/104412070.3